FDA 510(k)

ファシックスST 腹壁ヘルニアパッチ

K番号: K243241 · 2025-02-19

申請者Davol, Inc., A Subsidiary of C.R. Bard, Inc.

決定日2025-02-19

製品コードOWT

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Phasix ST Umbilical Hernia Patch is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc., A Subsidiary of C.R. Bard, Inc.. It received FDA 510(k) clearance on 2025-02-19 under 510(k) number K243241. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Phasix ST Umbilical Hernia Patch?

Phasix ST Umbilical Hernia Patch is a medical device that received FDA 510(k) clearance on 2025-02-19. The listed applicant is Davol, Inc., A Subsidiary of C.R. Bard, Inc.. The 510(k) number is K243241.

When did Phasix ST Umbilical Hernia Patch receive FDA 510(k) clearance?

Phasix ST Umbilical Hernia Patch received FDA 510(k) clearance on 2025-02-19, under 510(k) number K243241.

Who is the listed applicant for Phasix ST Umbilical Hernia Patch?

The FDA 510(k) record lists Davol, Inc., A Subsidiary of C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phasix ST Umbilical Hernia Patch?

The FDA product code for Phasix ST Umbilical Hernia Patch is OWT.

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ファシックスST 腹壁ヘルニアパッチ

医療機器の概要

よくある質問

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