510(k) K133513

MULTI-STAGE SNARE by United States Endoscopy Group, Inc. — Product Code FDI

K133513 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "MULTI-STAGE SNARE". The FDA issued a decision of Substantially Equivalent on December 20, 2013. 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
December 20, 2013
Date Received
November 12, 2013
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