INJECTOR NEEDLE/SNARE

Snare, Flexible

UNITED STATES ENDOSCOPY GROUP, INC.

The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Injector Needle/snare.

Pre-market Notification Details

Device IDK040961
510k NumberK040961
Device Name:INJECTOR NEEDLE/SNARE
ClassificationSnare, Flexible
Applicant UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor,  OH  44060
ContactGretchen Y Cohen
CorrespondentGretchen Y Cohen
UNITED STATES ENDOSCOPY GROUP, INC. 5976 HEISLEY RD. Mentor,  OH  44060
Product CodeFDI  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-13
Decision Date2004-07-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10724995180826 K040961 000
10724995180819 K040961 000
10724995180802 K040961 000
10724995180796 K040961 000

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