K181997 is an FDA 510(k) clearance for the Swiss LithoClast Trilogy. This device is classified as a Lithotriptor, Ultrasonic (Class II - Special Controls, product code FEO).
Submitted by E.M.S Electro Medical Systems S.A (Nyon, CH). The FDA issued a Cleared decision on August 30, 2018, 35 days after receiving the submission on July 26, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K181997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2018 |
| Decision Date | August 30, 2018 |
| Days to Decision | 35 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEO — Lithotriptor, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4480 |