510(k) K140923
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 Nov 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 15 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 18, 2014
- Date Received
- Apr 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
- 510(k)