K052048 is an FDA 510(k) clearance for the ACCORDION, a Dislodger, Stone, Basket, Ureteral, Metal (Class II — Special Controls, product code FFL), submitted by Percutaneous Systems, Incorporated (Mountain View, US). The FDA issued a Cleared decision on September 13, 2005, 46 days after receiving the submission on July 29, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K052048 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 2005 |
| Decision Date | September 13, 2005 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFL — Dislodger, Stone, Basket, Ureteral, Metal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4680 |