FDA 510(k)

GMReis 締縫アンカー

K番号: K252664 · 2025-11-04

申請者GM Dos Reis Industria e Comercio Ltda.

決定日2025-11-04

製品コードMBI

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

GMReis Suture Anchors 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 2025-11-04 under 510(k) number K252664. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the GMReis Suture Anchors?

GMReis Suture Anchors is a medical device that received FDA 510(k) clearance on 2025-11-04. The listed applicant is GM Dos Reis Industria e Comercio Ltda.. The 510(k) number is K252664.

When did GMReis Suture Anchors receive FDA 510(k) clearance?

GMReis Suture Anchors received FDA 510(k) clearance on 2025-11-04, under 510(k) number K252664.

Who is the listed applicant for GMReis Suture Anchors?

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 GMReis Suture Anchors?

The FDA product code for GMReis Suture Anchors is MBI.

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

K253910Stitch - Suture Wires and Tapes K262537Versalock Sterile Plating System K261406Versalock Proximal Tibial Plating System K260390Super Upper Limbs Versalock Plating System K254188関節鏡 Versaflex K243905Stitch Cerclage – Suture Tapes

すべての16件のデバイスを表示 →

公式ソース

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