FDA 510(k)

Revolve Surgical System

Número K: K243968 · 2025-10-03

Data da decisão2025-10-03

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Revolve Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Revolve Surgical, Inc.. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K243968. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Revolve Surgical System?

Revolve Surgical System is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Revolve Surgical, Inc.. The 510(k) number is K243968.

When did Revolve Surgical System receive FDA 510(k) clearance?

Revolve Surgical System received FDA 510(k) clearance on 2025-10-03, under 510(k) number K243968.

Who is the listed applicant for Revolve Surgical System?

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

What is the FDA product code for Revolve Surgical System?

The FDA product code for Revolve Surgical System is GCJ.

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