510(k) K202478 ยท FDI Snare, Flexible
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Oct 8, 2020 |
| Received | Aug 28, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202478
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2021 | Boston Scientific Corporation Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares.
Outer box UPN, Inner Pouch UPN:
M00561311 (Box 10), M00561310
M00562301 (Box 10), M00562300;
M00562321 (Box 10 Open, Classified |
FDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.