GENII GI 4000 ELECTROSUGICAL GENERATOR

Electrosurgical, Cutting & Coagulation & Accessories

GENII, INC.

The following data is part of a premarket notification filed by Genii, Inc. with the FDA for Genii Gi 4000 Electrosugical Generator.

Pre-market Notification Details

Device IDK113265
510k NumberK113265
Device Name:GENII GI 4000 ELECTROSUGICAL GENERATOR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant GENII, INC. 611 WEST 5TH FLOOR THIRD FLOOR Austin,  TX  78701
ContactJulie Powell
CorrespondentJulie Powell
GENII, INC. 611 WEST 5TH FLOOR THIRD FLOOR Austin,  TX  78701
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-04
Decision Date2012-03-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00724995209155 K113265 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.