FDA 510(k)

Cautery Protective Actuation System (CPAS)

Número K: K232407 · 2023-10-06

RequerenteSafer Surgeries Medical Devices, LLC

Data da decisão2023-10-06

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cautery Protective Actuation System (CPAS) is the device name listed in this FDA 510(k) record. The listed applicant is Safer Surgeries Medical Devices, LLC. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K232407. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cautery Protective Actuation System (CPAS)?

Cautery Protective Actuation System (CPAS) is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Safer Surgeries Medical Devices, LLC. The 510(k) number is K232407.

When did Cautery Protective Actuation System (CPAS) receive FDA 510(k) clearance?

Cautery Protective Actuation System (CPAS) received FDA 510(k) clearance on 2023-10-06, under 510(k) number K232407.

Who is the listed applicant for Cautery Protective Actuation System (CPAS)?

The FDA 510(k) record lists Safer Surgeries Medical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cautery Protective Actuation System (CPAS)?

The FDA product code for Cautery Protective Actuation System (CPAS) is GEI.

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