K172299 is an FDA 510(k) clearance for the Accordion Piccolo Stone Management Device. This device is classified as a Dislodger, Stone, Basket, Ureteral, Metal (Class II - Special Controls, product code FFL).
Submitted by Ths International, Inc. D/B/A Accordion Medical (Indianapolis, US). The FDA issued a Cleared decision on September 19, 2017, 50 days after receiving the submission on July 31, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4680.
| 510(k) Number | K172299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2017 |
| Decision Date | September 19, 2017 |
| Days to Decision | 50 days |
| Submission Type | Special |
| 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 |