510(k) K200745

Lariat, Hot/Cold Snare by United States Endoscopy Group, Inc. — Product Code FDI

K200745 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "Lariat, Hot/Cold Snare". The FDA issued a decision of Substantially Equivalent on April 21, 2020. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2020
Date Received
March 23, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Snare, Flexible
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type