FDA 510(k)

SmartRelease Endoscopic Soft Tissue Release System

Número K: K223406 · 2023-02-02

RequerenteMicroaire Surgical Instruments

Data da decisão2023-02-02

Código do produtoHRX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SmartRelease Endoscopic Soft Tissue Release System is the device name listed in this FDA 510(k) record. The listed applicant is Microaire Surgical Instruments. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K223406. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SmartRelease Endoscopic Soft Tissue Release System?

SmartRelease Endoscopic Soft Tissue Release System is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Microaire Surgical Instruments. The 510(k) number is K223406.

When did SmartRelease Endoscopic Soft Tissue Release System receive FDA 510(k) clearance?

SmartRelease Endoscopic Soft Tissue Release System received FDA 510(k) clearance on 2023-02-02, under 510(k) number K223406.

Who is the listed applicant for SmartRelease Endoscopic Soft Tissue Release System?

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

What is the FDA product code for SmartRelease Endoscopic Soft Tissue Release System?

The FDA product code for SmartRelease Endoscopic Soft Tissue Release System is HRX.

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Outros registros que listam Microaire Surgical Instruments como candidato(a)

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