K970121 is an FDA 510(k) clearance for the STONE DISLODGER, BASKET. This device is classified as a Dislodger, Stone, Flexible (Class II - Special Controls, product code FGO).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on April 2, 1997, 78 days after receiving the submission on January 14, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K970121 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 1997 |
| Decision Date | April 02, 1997 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGO — Dislodger, Stone, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4680 |