免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Progrip™ 自攝式聚丙烯網格

K 號：K232373 · 2024-01-18

申請人Sofradim Production
決定日期2024-01-18
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™ Self-Gripping Polypropylene Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K232373. 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™ Self-Gripping Polypropylene Mesh?

Progrip™ Self-Gripping Polypropylene Mesh is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Sofradim Production. The 510(k) number is K232373.

When did Progrip™ Self-Gripping Polypropylene Mesh receive FDA 510(k) clearance?

Progrip™ Self-Gripping Polypropylene Mesh received FDA 510(k) clearance on 2024-01-18, under 510(k) number K232373.

Who is the listed applicant for Progrip™ Self-Gripping Polypropylene Mesh?

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™ Self-Gripping Polypropylene Mesh?

The FDA product code for Progrip™ Self-Gripping Polypropylene Mesh is FTL.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K253956ProGrip™ 先進自緊握聚丙烯網格 (ADG1510, ADG2015, ADG3020, ADG4030)K250869Parietene™ 大孔網膜 (PPM5050)K243315ProGrip™ 自粘性聚丙烯網K233661Transorb™ 自粘性可吸收網格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

查看所有 11 項裝置 →

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。

K253956ProGrip™ 先進自緊握聚丙烯網格 (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ 平面網狀布Medtronic - Sofradim ProductionK251955Onflex™ 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 ProductionK250098巴德柔 mesh；巴德柔柔 mesh 預成型Davol, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑