K111058 is an FDA 510(k) clearance for the URETRON MODEL URT, a Lithotriptor, Electro-hydraulic (Class II — Special Controls, product code FFK), submitted by Med-Sonics Corp. (Erie, US). The FDA issued a Cleared decision on March 30, 2012, 347 days after receiving the submission on April 18, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K111058 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 18, 2011 |
| Decision Date | March 30, 2012 |
| Days to Decision | 347 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFK — Lithotriptor, Electro-hydraulic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4480 |