510(k) K182909

Roth Net Retriever Product Line by United States Endoscopy Group, Inc. — Product Code FDI

K182909 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "Roth Net Retriever Product Line". The FDA issued a decision of Substantially Equivalent on November 21, 2018. 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
November 21, 2018
Date Received
October 17, 2018
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