K123038 is an FDA 510(k) clearance for the SWISS LITHOBREAKER. This device is classified as a Lithotriptor, Electro-hydraulic (Class II - Special Controls, product code FFK).
Submitted by E.M.S Electro Medical Systems S.A (Southbrough, US). The FDA issued a Cleared decision on January 16, 2013, 110 days after receiving the submission on September 28, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K123038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2012 |
| Decision Date | January 16, 2013 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| 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 |