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FDA 510(k)

ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); Sistema WEREWOLF COBLATION (72290144); Sistema WEREWOLF+ COBLATION (72290146)

Número K: K230914 · 2023-06-26

RequerenteArthroCare Corporation
Data da decisão2023-06-26
Código do produtoGEI
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2023-06-26 under 510(k) number K230914. 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 ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)?

ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) is a medical device that received FDA 510(k) clearance on 2023-06-26. The listed applicant is ArthroCare Corporation. The 510(k) number is K230914.

When did ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) receive FDA 510(k) clearance?

ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) received FDA 510(k) clearance on 2023-06-26, under 510(k) number K230914.

Who is the listed applicant for ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)?

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 ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146)?

The FDA product code for ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOLF COBLATION System (72290144); WEREWOLF+ COBLATION System (72290146) is GEI.

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