510(k) K140923

TRACTION POLYPECTOMY SNARE by Ovesco Endoscopy AG — Product Code FDI

K140923 is an FDA 510(k) premarket notification submitted by Ovesco Endoscopy AG for the device "TRACTION POLYPECTOMY SNARE". The FDA issued a decision of Substantially Equivalent on November 18, 2014. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Ovesco Endoscopy AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2014
Date Received
April 10, 2014
Clearance Type
Traditional
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