Ambient KVac Wand With Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)

Electrosurgical, Cutting & Coagulation & Accessories

ArthroCare Corporation

The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Ambient Kvac Wand With Integrated Finger Switches (ambient Kvac Ifs), Kvac Integrated Cable Wand (kvac Icw).

Pre-market Notification Details

Device IDK162126
510k NumberK162126
Device Name:Ambient KVac Wand With Integrated Finger Switches (Ambient KVac IFS), KVac Integrated Cable Wand (KVac ICW)
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ArthroCare Corporation 7000 West William Cannon Drive Austin,  TX  78735
ContactAshley M. Johnson
CorrespondentAshley M. Johnston
ArthroCare Corporation 7000 West William Cannon Drive Austin,  TX  78735
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-01
Decision Date2016-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817470000290 K162126 000
00817470000252 K162126 000

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