K001563 is an FDA 510(k) clearance for the SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET, a Dislodger, Stone, Flexible (Class II — Special Controls, product code FGO), submitted by Scion Cardiovascular, Inc. (Miami, US). The FDA issued a Cleared decision on November 22, 2000, 187 days after receiving the submission on May 19, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K001563 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 19, 2000 |
| Decision Date | November 22, 2000 |
| Days to Decision | 187 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 |