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FDA 510(k)

Parietex 外科網膜（改良為 Parietex 水性 2D、3D、解剖網膜），Parietex 复合網膜（PCO 及 PCO-OS 參考資料），Parietex 優化複合網膜（PCO-X、PCO-FX 及 PCO-OSX 參考資料）

K 號：K173796 · 2018-03-09

申請人Sofradim Production
決定日期2018-03-09
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

Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2018-03-09 under 510(k) number K173796. 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 Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)?

Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Sofradim Production. The 510(k) number is K173796.

When did Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) receive FDA 510(k) clearance?

Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) received FDA 510(k) clearance on 2018-03-09, under 510(k) number K173796.

Who is the listed applicant for Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)?

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 Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)?

The FDA product code for Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) 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K232373Progrip™ 自攝式聚丙烯網格K223218帕瑞特尼大孔網

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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。

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

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