HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL

Electrosurgical, Cutting & Coagulation & Accessories

CONMED CORPORATION

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Helixar Electrosurgical Generator With Argon Beam Coagulation, Helixar Mobile Pedestal.

Pre-market Notification Details

Device IDK152860
510k NumberK152860
Device Name:HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant CONMED CORPORATION 525 FRENCH ROAD Utica,  NY  13502
ContactLisa Anderson
CorrespondentLisa Anderson
CONMED CORPORATION 525 FRENCH ROAD Utica,  NY  13502
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-30
Decision Date2015-12-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20653405001970 K152860 000
20653405001994 K152860 000
30653405000758 K152860 000
10653405005537 K152860 000

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