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FDA 510(k)

WEREWOLF COBLATION System, COBLATION HALO Wand

K-Number: K192027 · 2019-12-20

ApplicantArthroCare Corporation
Decision Date2019-12-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WEREWOLF COBLATION System, COBLATION HALO Wand is a medical device manufactured by ArthroCare Corporation. It received FDA 510(k) clearance on 2019-12-20 under approval number K192027. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by ArthroCare Corporation. The 510(k) number is K192027.

When was WEREWOLF COBLATION System, COBLATION HALO Wand approved by the FDA?

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

What company makes WEREWOLF COBLATION System, COBLATION HALO Wand?

WEREWOLF COBLATION System, COBLATION HALO Wand is manufactured by ArthroCare Corporation.

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.

Other Devices by ArthroCare Corporation

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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