FDA 510(k)

Benesta Tissue Removal Device

Número K: K233500 · 2023-11-30

Data da decisão2023-11-30

Código do produtoHIH

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Benesta Tissue Removal Device is the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical, Inc.. It received FDA 510(k) clearance on 2023-11-30 under 510(k) number K233500. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Benesta Tissue Removal Device?

Benesta Tissue Removal Device is a medical device that received FDA 510(k) clearance on 2023-11-30. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K233500.

When did Benesta Tissue Removal Device receive FDA 510(k) clearance?

Benesta Tissue Removal Device received FDA 510(k) clearance on 2023-11-30, under 510(k) number K233500.

Who is the listed applicant for Benesta Tissue Removal Device?

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

What is the FDA product code for Benesta Tissue Removal Device?

The FDA product code for Benesta Tissue Removal Device is HIH.

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Fonte oficial

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