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Suture, Nonabsorbable, Synthetic, Polypropylene（GAW）
非吸収性合成ポリプロピレン縫合糸 この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。
26 件
直近 2025.02.12
85 件
25 件
20,018 件
分類情報
| Product Code | GAW |
|---|---|
| デバイス名 | Suture, Nonabsorbable, Synthetic, Polypropylene 非吸収性合成ポリプロピレン縫合糸 この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。 |
| デバイスクラス | クラス II |
| 21 CFR 規制番号 | 878.5010 |
| 審査区分 | 510(k)（市販前届出） |
| 医療専門分野 | 一般・形成外科 |
| 定義 | － |
| フラグ | インプラント機器 |
| AI分析 | この製品は米国においてクラスIIに分類される医療機器です。クラスIIは中程度のリスクを有する機器に適用される区分であり、市販前届出（510(k)）による審査を経て、既存の同等品との実質的同等性が確認されることで市販が認められます。 米国市場での動向 本製品コードでは、510(k)による市販前届出が累計約90件申請されており、参入企業は約60社、直近5年間では約5件の届出が確認されています。不具合報告は累計約19,600件で、その大半がMalfunction（不具合）に分類され、死亡報告は226件、傷害報告は約3,400件となっており、主な問題としてBreak（破断）、Material Separation（材料分離）、Detachment of Device or Device Component（機器または部品の脱落）が挙げられています。回収は累計約30件で、クラスIIが約25件、クラスI・クラスIIIは確認されておらず、直近5年間では約5件、最新の回収開始は2024年12月です。 この分析は公開データ（openFDA・JMDN 対応情報）をもとに AI が生成した参考情報です。市場データは2026年8月時点の集計に基づきます。 |
関連 product code
同じ 21 CFR 878.5010 に分類される product code（1 件）
| No. | product code | 機器名 | クラス | 専門分野 | 510(k) | PMA | 不具合 | 回収 |
|---|---|---|---|---|---|---|---|---|
| 1 | MXW | Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride) 非吸収性縫合糸（ポリフッ化ビニリデン製） | II | 一般・形成外科 | 2 | — | — | — |
機器名の日本語訳は AI により自動生成したものです。正確には英語原文をご確認ください。
類似の国内医療機器（自動推定）
FDA デバイス分類と JMDN 英語名の名称・定義文の類似度から機械的に推定した候補です。日米の当局が定めた公的な対応関係ではなく、参考情報としてご覧ください。
| No. | 類別 | 一般的名称 | 品目数 | 企業数 | 年間総出荷額 | 成長率 | 平均価格 | 国産比率 |
|---|---|---|---|---|---|---|---|---|
| 1 | 縫合糸 | 合成吸収性縫合糸クラスⅣ | 1 | 1 | — | — | — | — |
| 2 | 縫合糸 | ポリプロピレン縫合糸クラスⅢ | 22 | 16 | 37.42 億円/年 | +7.9% | 3,412 円/個 | 71.2% |
| 3 | 縫合糸 | 非吸収性縫合糸セットクラスⅢ | 8 | 7 | 48.1 億円/年 | +14.8% | 2.09 万円/個 | 12.1% |
| 4 | 縫合糸 | 吸収性縫合糸クラスⅣ | — | — | — | — | — | — |
| 5 | 縫合糸 | ポリエチレン・ポリジオキサノン縫合糸クラスⅣ | — | — | — | — | — | — |
FDA のデバイスクラスは 3 段階（クラス I〜III）、日本の医療機器は 4 段階（クラス I〜IV）で分類されており、 1 対 1 では対応しません。 リスク区分の考え方が異なるため、参考情報としてご利用ください。
米国での回収・承認・不具合報告
米国回収
全 26 件| 回収番号 | クラス | 回収開始日 | 企業 | 理由 | ステータス |
|---|---|---|---|---|---|
| Z-1098-2025 GAW | クラス II | 2024.12.20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection. | 対応中 |
| Z-1097-2025 GAW | クラス II | 2024.12.20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection. | 対応中 |
| Z-1096-2025 GAW | クラス II | 2024.12.20 | Ethicon, LLC | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection. | 対応中 |
| Z-1180-2023 GAW | クラス II | 2022.12.02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 対応中 |
| Z-1179-2023 GAW | クラス II | 2022.12.02 | Covidien, LP | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 対応中 |
| Z-2466-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2465-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2464-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2463-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2462-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2461-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2460-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2459-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2458-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2457-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2456-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2455-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2454-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2453-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
| Z-2452-2018 GAW | クラス II | 2018.05.07 | Ethicon, Inc. | The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional. | 終了 |
510(k)（市販前届出）
全 85 件| No. | 番号 | 機器名 | 申請者 | 決定日 | 種別 | 概要 |
|---|---|---|---|---|---|---|
| 1 | K253572 | STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2026.03.27 | 通常（Traditional） | |
| 2 | K233355 | Cypris eXact Suturing System | Cypris Medical | 2024.01.12 | 通常（Traditional） | |
| 3 | K230746 | Non absorbable Surgical Polypropylene Suture | Shandong Haidike Medical Products Co., Ltd. | 2023.09.14 | 通常（Traditional） | |
| 4 | K221280 | Vesseal | Lydus Medical , Ltd. | 2022.12.09 | 通常（Traditional） | |
| 5 | K211178 | DURAMESH Mesh Suture | Msi | 2022.09.02 | 通常（Traditional） | |
| 6 | K192953 | APTOS Threads Polypropylene Surgical Sutures | Aptos, LLC | 2020.08.27 | 通常（Traditional） | |
| 7 | K193530 | Deklene MAXX | Teleflex Medical | 2020.03.19 | 特別（Special） | |
| 8 | K191299 | Silhouette Featherlift / Silhouette Lift | Silhouette Lift, Inc. | 2019.06.14 | 特別（Special） | |
| 9 | K173747 | REXLENE | Sm Eng Co., Ltd. | 2018.12.21 | 通常（Traditional） | |
| 10 | K180321 | Aesculap Optilene Nonabsorbable Suture | Aesculap, Inc. | 2018.03.07 | 特別（Special） | |
| 11 | K173644 | Gazelle Polypropylene Suture and Delivery Device | Dura Tap, LLC | 2018.02.15 | 簡略（Abbreviated） | |
| 12 | K171039 | Assut Filbloc Permanent Sutures | Assut Europe S.P.A. | 2017.08.29 | 簡略（Abbreviated） | |
| 13 | K171005 | Silhouette Featherlift | Silhouette Lift, Inc. | 2017.05.03 | 特別（Special） | |
| 14 | K162617 | NobleStitch EL | Nobles Medical Technologies Ii, Inc. | 2017.04.06 | 簡略（Abbreviated） | |
| 15 | K160529 | Pledgeted COR-SUTURE QUICK LOAD | Lsi Soultions | 2016.09.15 | 簡略（Abbreviated） | |
| 16 | K143582 | MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL | Resorba Medical GmbH | 2015.10.29 | 通常（Traditional） | |
| 17 | K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design | Angiotech | 2015.09.10 | 特別（Special） | |
| 18 | K141206 | EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM | Edwards Lifesciences, LLC | 2015.01.16 | 通常（Traditional） | |
| 19 | K142639 | StitchKit | Origami Surgical, LLC | 2014.12.16 | 通常（Traditional） | |
| 20 | K133890 | AESCULAP OPTILENE NONABSORBABLE SUTURE | Aesculap, Inc. | 2014.07.15 | 通常（Traditional） |
出典の openFDA は各 510(k) の主要（primary）product code のみを収録しているため、副次コードを含む FDA 公式データベースの検索結果とは件数が異なる場合があります。 FDA 510(k) データベースで確認
PMA（市販前承認）
全 25 件| PMA 番号 | 販売名 | 申請者 | 決定日 |
|---|---|---|---|
| P820083/S025 | GORE-TEX(TM) SUTURE | W. L. Gore & Associates, Inc. | 1998.08.27 |
| P820083/S024 | GORE-TEX(TM) SUTURE | W. L. Gore & Associates, Inc. | 1996.10.03 |
| P820083/S023 | GORE-TEX(TM) SUTURE | W. L. Gore & Associates, Inc. | 1996.10.03 |
| P820083/S022 | GORE-TEX SUTURE WITH PLEDGETS | W. L. Gore & Associates, Inc. | 1996.09.24 |
| P820083/S021 | GORE-TEX(R) SUTURE | W. L. Gore & Associates, Inc. | 1996.09.24 |
| P820083/S020 | GORE-TEX(R) SUTURE | W. L. Gore & Associates, Inc. | 1995.06.05 |
| P820083/S019 | GORE-TEX(R) SUTURE | W. L. Gore & Associates, Inc. | 1995.01.23 |
| P820083/S017 | GORE-TEX(R) SUTURE | W. L. Gore & Associates, Inc. | 1994.08.19 |
| P820083/S018 | GORE-TEX(R) SUTURE | W. L. Gore & Associates, Inc. | 1994.08.11 |
| P820083/S015 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1994.04.08 |
| P820083/S016 | GORE-TEX(R) SUTURE | W. L. Gore & Associates, Inc. | 1994.01.10 |
| P820083/S014 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1993.10.15 |
| P820083/S013 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1993.07.01 |
| P820083/S012 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1990.10.19 |
| P890002 | POLYPROPYLENE SURGICAL SUTURE | Alcon Laboratories | 1989.05.31 |
| P820083/S010 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1989.05.26 |
| P820083/S008 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1989.05.02 |
| P820083/S009 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1989.03.09 |
| P820083/S007 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1989.03.09 |
| P820083/S006 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. | 1987.12.14 |
不具合報告（MAUDE）トレンド
米国不具合報告検索で詳しく見る出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
報告の存在は、機器と事象の因果関係を意味しません。報告件数を機器間の不具合発生率の比較に用いることはできません。
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。
出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
取得日: 2026.09.28
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。