510(k) K133987 ยท FDI Snare, Flexible
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Jan 24, 2014 |
| Received | Dec 26, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133987
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2021 | Boston Scientific Corporation Captivator II Single-Use Polypectomy Snares
Outer box UPN, Inner Pouch UPN:
M00561191 (Box 10), M00561190;
M00561221 (Box 10), M00561220;
M00561222 (Box 20), M00561220;
M00561223 (Box 40), M Open, Classified |
FDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.