PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
FDA 510(k) clearance K941750 · decided 1994-11-01
Clearance details
- K-number
- K941750
- Device name
- PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1994-04-08
- Decision date
- 1994-11-01
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- FDI
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Po recall (Z-1850-2012) | Boston Scientific Corporation | 2012-06-21 |
| Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner P recall (Z-1851-2012) | Boston Scientific Corporation | 2012-06-21 |
| Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner P recall (Z-1852-2012) | Boston Scientific Corporation | 2012-06-21 |