FDA 510(k)

Stitch Cerclage – Suture Tapes

K番号: K243905 · 2025-08-14

申請者GM Dos Reis Industria e Comercio Ltda.

決定日2025-08-14

製品コードJDQ

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定Substantially Equivalent

医療機器の概要

Stitch Cerclage – Suture Tapes is the device name listed in this FDA 510(k) record. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. It received FDA 510(k) clearance on 2025-08-14 under 510(k) number K243905. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Stitch Cerclage – Suture Tapes?

Stitch Cerclage – Suture Tapes is a medical device that received FDA 510(k) clearance on 2025-08-14. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K243905.

When did Stitch Cerclage – Suture Tapes receive FDA 510(k) clearance?

Stitch Cerclage – Suture Tapes received FDA 510(k) clearance on 2025-08-14, under 510(k) number K243905.

Who is the listed applicant for Stitch Cerclage – Suture Tapes?

The FDA 510(k) record lists GM Dos Reis Industria e Comercio Ltda. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stitch Cerclage – Suture Tapes?

The FDA product code for Stitch Cerclage – Suture Tapes is JDQ.

申請者としてGM Dos Reis Industria e Comercio Ltda.を記載するその他の記録

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