GS-5000 SPATULA SUCTION/COAGULATOR, 5MM

Electrosurgical, Cutting & Coagulation & Accessories

SOLOS ENDOSCOPY, INC.

The following data is part of a premarket notification filed by Solos Endoscopy, Inc. with the FDA for Gs-5000 Spatula Suction/coagulator, 5mm.

Pre-market Notification Details

Device IDK900953
510k NumberK900953
Device Name:GS-5000 SPATULA SUCTION/COAGULATOR, 5MM
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant SOLOS ENDOSCOPY, INC. 6191 ATLANTIC BLVD. SUITE 4 Norcross,  GA  30071
ContactLeila H Holmes
CorrespondentLeila H Holmes
SOLOS ENDOSCOPY, INC. 6191 ATLANTIC BLVD. SUITE 4 Norcross,  GA  30071
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-27
Decision Date1990-04-18

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