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FDA 510(k)

Parietene™ 平面網狀布

K 號：K253125 · 2025-10-24

申請人Medtronic - Sofradim Production
決定日期2025-10-24
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

Parietene™ Flat Sheet Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic - Sofradim Production. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K253125. 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 Parietene™ Flat Sheet Mesh?

Parietene™ Flat Sheet Mesh is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Medtronic - Sofradim Production. The 510(k) number is K253125.

When did Parietene™ Flat Sheet Mesh receive FDA 510(k) clearance?

Parietene™ Flat Sheet Mesh received FDA 510(k) clearance on 2025-10-24, under 510(k) number K253125.

Who is the listed applicant for Parietene™ Flat Sheet Mesh?

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

What is the FDA product code for Parietene™ Flat Sheet Mesh?

The FDA product code for Parietene™ Flat Sheet 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

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 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.K243315ProGrip™ 自粘性聚丙烯網Sofradim Production

官方來源

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