FDA 510(k)

All-Suture Dual Anchor System

Número K: K250095 · 2025-09-05

Data da decisão2025-09-05

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

All-Suture Dual Anchor System is the device name listed in this FDA 510(k) record. The listed applicant is Suturetech, Inc.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K250095. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the All-Suture Dual Anchor System?

All-Suture Dual Anchor System is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Suturetech, Inc.. The 510(k) number is K250095.

When did All-Suture Dual Anchor System receive FDA 510(k) clearance?

All-Suture Dual Anchor System received FDA 510(k) clearance on 2025-09-05, under 510(k) number K250095.

Who is the listed applicant for All-Suture Dual Anchor System?

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

What is the FDA product code for All-Suture Dual Anchor System?

The FDA product code for All-Suture Dual Anchor System is MBI.

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