FDA 510(k)

WEREWOLF COBLATION System, COBLATION HALO Wand

Número K: K192027 · 2019-12-20

Data da decisão2019-12-20

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

WEREWOLF COBLATION System, COBLATION HALO Wand is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K192027. 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 WEREWOLF COBLATION System, COBLATION HALO Wand?

WEREWOLF COBLATION System, COBLATION HALO Wand is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is ArthroCare Corporation. The 510(k) number is K192027.

When did WEREWOLF COBLATION System, COBLATION HALO Wand receive FDA 510(k) clearance?

WEREWOLF COBLATION System, COBLATION HALO Wand received FDA 510(k) clearance on 2019-12-20, under 510(k) number K192027.

Who is the listed applicant for WEREWOLF COBLATION System, COBLATION HALO Wand?

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

What is the FDA product code for WEREWOLF COBLATION System, COBLATION HALO Wand?

The FDA product code for WEREWOLF COBLATION System, COBLATION HALO Wand is GEI.

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