Lariat, Hot/Cold 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 Lariat, Hot/cold Snare.

Pre-market Notification Details

Device IDK200745
510k NumberK200745
Device Name:Lariat, Hot/Cold Snare
ClassificationSnare, Flexible
Applicant United States Endoscopy Group, Inc. 5976 Heisley Road Mentor,  OH  44060
ContactCarroll Martin
CorrespondentCarroll Martin
United States Endoscopy Group, Inc. 5976 Heisley Road Mentor,  OH  44060
Product CodeFDI  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-23
Decision Date2020-04-21

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