Rotatable Snares
FDA 510(k) clearance K160637 · decided 2016-03-30
Clearance details
- K-number
- K160637
- Device name
- Rotatable Snares
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2016-03-07
- Decision date
- 2016-03-30
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- FDI
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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