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

Electrosurgical, Cutting & Coagulation & Accessories

ArthroCare Corporation

The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Ent Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf Ent Adapter, Werewolf Coblation System.

Pre-market Notification Details

Device IDK202006
510k NumberK202006
Device Name:ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ArthroCare Corporation 7000 West William Cannon Drive, Building One Austin,  TX  78749
ContactJean Asquith
CorrespondentJean Asquith
ArthroCare Corporation 7000 West William Cannon Drive, Building One Austin,  TX  78749
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-21
Decision Date2020-12-18

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