K012445 is an FDA 510(k) clearance for the EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA). This device is classified as a Lithotriptor, Electro-hydraulic (Class II - Special Controls, product code FFK).
Submitted by Electro Medical Systems SA (North Attleboro, US). The FDA issued a Cleared decision on August 24, 2001, 23 days after receiving the submission on August 1, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K012445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2001 |
| Decision Date | August 24, 2001 |
| Days to Decision | 23 days |
| Submission Type | Special |
| 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 |