RF20000a Controller, FLOW 50 Wand

Electrosurgical, Cutting & Coagulation & Accessories

ARTHROCARE CORPORATION

The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Rf20000a Controller, Flow 50 Wand.

Pre-market Notification Details

Device IDK143235
510k NumberK143235
Device Name:RF20000a Controller, FLOW 50 Wand
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant ARTHROCARE CORPORATION 7000 WEST WILLIAM CANNON DRIVE Austin,  TX  78735
ContactAshley J Dawson
CorrespondentAshley J Dawson
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 Received2014-11-10
Decision Date2015-10-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817470012217 K143235 000
00885556724668 K143235 000
00885556617472 K143235 000

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