K191789 is an FDA 510(k) clearance for the Stonetome Stone Removal Device. This device is classified as a Dislodger, Stone, Biliary (Class II - Special Controls, product code LQR).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on July 25, 2019, 22 days after receiving the submission on July 3, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K191789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | July 03, 2019 |
| Decision Date | July 25, 2019 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LQR — Dislodger, Stone, Biliary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5010 |