Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand

Electrosurgical, Cutting & Coagulation & Accessories

Arthrocare Corporation

The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand.

Pre-market Notification Details

Device IDK210423
510k NumberK210423
Device Name:Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Arthrocare Corporation 7000 West William Cannon Drive Building One Austin,  TX  78735
ContactShruthi Bhat
CorrespondentShruthi Bhat
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 Received2021-02-11
Decision Date2021-06-24

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