FDA 510(k)

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps

Número K: K213610 · 2022-10-07

Data da decisão2022-10-07

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Katalyst Surgical, LLC. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K213610. 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 Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps?

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Katalyst Surgical, LLC. The 510(k) number is K213610.

When did Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps receive FDA 510(k) clearance?

Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps received FDA 510(k) clearance on 2022-10-07, under 510(k) number K213610.

Who is the listed applicant for Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps?

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

What is the FDA product code for Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps?

The FDA product code for Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps is GEI.

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Fonte oficial

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