FDA 510(k)

ProCell Surgical Sponge-Blood Recovery Unit

Número K: K193361 · 2020-06-01

Data da decisão2020-06-01

Código do produtoCAC

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

ProCell Surgical Sponge-Blood Recovery Unit is the device name listed in this FDA 510(k) record. The listed applicant is Procell Surgical, Inc.. It received FDA 510(k) clearance on 2020-06-01 under 510(k) number K193361. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ProCell Surgical Sponge-Blood Recovery Unit?

ProCell Surgical Sponge-Blood Recovery Unit is a medical device that received FDA 510(k) clearance on 2020-06-01. The listed applicant is Procell Surgical, Inc.. The 510(k) number is K193361.

When did ProCell Surgical Sponge-Blood Recovery Unit receive FDA 510(k) clearance?

ProCell Surgical Sponge-Blood Recovery Unit received FDA 510(k) clearance on 2020-06-01, under 510(k) number K193361.

Who is the listed applicant for ProCell Surgical Sponge-Blood Recovery Unit?

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

What is the FDA product code for ProCell Surgical Sponge-Blood Recovery Unit?

The FDA product code for ProCell Surgical Sponge-Blood Recovery Unit is CAC.

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Fonte oficial

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