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FDA 510(k)

ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System

K-Number: K202006 · 2020-12-18

ApplicantArthroCare Corporation
Decision Date2020-12-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System is a medical device manufactured by ArthroCare Corporation. It received FDA 510(k) clearance on 2020-12-18 under approval number K202006. 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 ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System?

ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System is a medical device that received FDA 510(k) clearance on 2020-12-18. It is manufactured by ArthroCare Corporation. The 510(k) number is K202006.

When was ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System approved by the FDA?

ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System received FDA 510(k) clearance on 2020-12-18, under approval number K202006.

What company makes ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System?

ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System is manufactured by ArthroCare Corporation.

What is the FDA product code for ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System?

The FDA product code for ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System is GEI.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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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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