Ambient HipVac 50 Wand With Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, 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 Ambient Hipvac 50 Wand With Integrated Finger Switches, Rf20000 Coblation System, Werewolf Coblation System, Werewolf+ Coblation System.

Pre-market Notification Details

Device IDK220563
510k NumberK220563
Device Name:Ambient HipVac 50 Wand With Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Arthrocare Corporation 7000 West William Cannon Drive Building One Austin,  TX  78735
ContactAlexander Brankner
CorrespondentAlexander Brankner
Arthrocare Corporation 7000 West William Cannon Drive Building One Austin,  TX  78735
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-28
Decision Date2022-09-01

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