FDA 510(k)

巴德® 網膜；巴德® 預成型網膜

K 號：K251557 · 2025-06-12

決定日期2025-06-12

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

Bard® Mesh; Bard® Mesh Pre-Shaped is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K251557. 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 Bard® Mesh; Bard® Mesh Pre-Shaped?

Bard® Mesh; Bard® Mesh Pre-Shaped is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Davol, Inc.. The 510(k) number is K251557.

When did Bard® Mesh; Bard® Mesh Pre-Shaped receive FDA 510(k) clearance?

Bard® Mesh; Bard® Mesh Pre-Shaped received FDA 510(k) clearance on 2025-06-12, under 510(k) number K251557.

Who is the listed applicant for Bard® Mesh; Bard® Mesh Pre-Shaped?

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

What is the FDA product code for Bard® Mesh; Bard® Mesh Pre-Shaped?

The FDA product code for Bard® Mesh; Bard® Mesh Pre-Shaped is FTL.

其他以 Davol, Inc. 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。

K250098巴德柔 mesh；巴德柔柔 mesh 預成型

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 Production K253125Parietene™ 平面網狀布Medtronic - Sofradim Production K251955Onflex™ 網狀物Davol Inc., Subsidiary of C. R. Bard, 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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