SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY

Electrosurgical, Cutting & Coagulation & Accessories

CONMED ELECTROSURGERY

The following data is part of a premarket notification filed by Conmed Electrosurgery with the FDA for System 7500-b Electrosurgical Unit; Abcflex Probe For Flexible Endoscopy.

Pre-market Notification Details

Device IDK050161
510k NumberK050161
Device Name:SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant CONMED ELECTROSURGERY 14603 E. FREMONT AVE. Centennial,  CO  80112
ContactPamela Vetter
CorrespondentPamela Vetter
CONMED ELECTROSURGERY 14603 E. FREMONT AVE. Centennial,  CO  80112
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-25
Decision Date2005-02-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20653405043437 K050161 000
20653405043420 K050161 000
10653405002987 K050161 000

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