The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Captivator Single-use Polypectomy Snares, Captiflex Single-use Polypectomy Snares.
| Device ID | K202478 |
| 510k Number | K202478 |
| Device Name: | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares |
| Classification | Snare, Flexible |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Stephanie Gorman |
| Correspondent | Stephanie Gorman Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-28 |
| Decision Date | 2020-10-08 |