FDA 510(k)

ProGrip™ 先進自緊握聚丙烯網格 (ADG1510, ADG2015, ADG3020, ADG4030)

K 號：K253956 · 2026-05-21

決定日期2026-05-21

產品代碼FTL

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K253956. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)?

ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Sofradim Production. The 510(k) number is K253956.

When did ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) receive FDA 510(k) clearance?

ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) received FDA 510(k) clearance on 2026-05-21, under 510(k) number K253956.

Who is the listed applicant for ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)?

The FDA 510(k) record lists Sofradim Production as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)?

The FDA product code for ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) is FTL.

其他以 Sofradim Production 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250869Parietene™ 大孔網膜 (PPM5050)K243315ProGrip™ 自粘性聚丙烯網 K233661Transorb™ 自粘性可吸收網格 K232373Progrip™ 自攝式聚丙烯網格 K223218帕瑞特尼大孔網 K220586Symbotex複合網膜，ProGrip自握聚酯網膜，Parietex親水性2D 3D解剖網膜，Versatex單絲網膜

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相關器械（代碼：FTL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253125Parietene™ 平面網狀布Medtronic - Sofradim Production K251955Onflex™ 網狀物Davol Inc., Subsidiary of C. R. Bard, Inc.K251557巴德® 網膜；巴德® 預成型網膜Davol, Inc.K250869Parietene™ 大孔網膜 (PPM5050)Sofradim Production K250098巴德柔 mesh；巴德柔柔 mesh 預成型Davol, Inc.K243315ProGrip™ 自粘性聚丙烯網Sofradim Production

官方來源

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