Ambient HipVac 50 Wand With Integrated Finger Switches

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.

Pre-market Notification Details

Device IDK161481
510k NumberK161481
Device Name:Ambient HipVac 50 Wand With Integrated Finger Switches
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE Austin,  TX  78735
ContactAshley M. Johnston
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 Received2016-05-31
Decision Date2016-10-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885556614686 K161481 000

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