The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Stonetome Stone Removal Device.
| Device ID | K191789 |
| 510k Number | K191789 |
| Device Name: | Stonetome Stone Removal Device |
| Classification | Dislodger, Stone, Biliary |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Laura Kuroski |
| Correspondent | Laura Kuroski Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | LQR |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-03 |
| Decision Date | 2019-07-25 |
| Summary: | summary |