The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Spyglass Discover Retrieval Basket.
| Device ID | K203322 |
| 510k Number | K203322 |
| Device Name: | SpyGlass Discover Retrieval Basket |
| Classification | Dislodger, Stone, Biliary |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01749 |
| Contact | Lindsay Forys |
| Correspondent | Lindsay Forys Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01749 |
| Product Code | LQR |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-12 |
| Decision Date | 2021-05-26 |