K230488 is an FDA 510(k) clearance for the EL27-Compact. This device is classified as a Lithotriptor, Electro-hydraulic (Class II - Special Controls, product code FFK).
Submitted by Walz Elektronik GmbH (Rohrdorf, DE). The FDA issued a Cleared decision on August 31, 2023, 189 days after receiving the submission on February 23, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K230488 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2023 |
| Decision Date | August 31, 2023 |
| Days to Decision | 189 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 |