FDA 510(k)

バーベッドPDO縫合糸

K番号: K252171 · 2026-06-12

決定日2026-06-12

製品コードNEW

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

Barbed PDO Suture is the device name listed in this FDA 510(k) record. The listed applicant is Sutura Medical Technology, Inc.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K252171. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Barbed PDO Suture?

Barbed PDO Suture is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Sutura Medical Technology, Inc.. The 510(k) number is K252171.

When did Barbed PDO Suture receive FDA 510(k) clearance?

Barbed PDO Suture received FDA 510(k) clearance on 2026-06-12, under 510(k) number K252171.

Who is the listed applicant for Barbed PDO Suture?

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

What is the FDA product code for Barbed PDO Suture?

The FDA product code for Barbed PDO Suture is NEW.

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バーベッドPDO縫合糸

医療機器の概要

よくある質問

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