510(k) K160637
K160637 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Rotatable Snares". The FDA issued a decision of Substantially Equivalent on March 30, 2016. The device falls under product code FDI (Snare, Flexible), a Class II device regulated under 21 CFR 876.4300. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2016
- Date Received
- March 7, 2016
- 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