K242922 is an FDA 510(k) clearance for the Extracorporeal Shock Wave Lithotripter (U200). This device is classified as a Lithotriptor, Extracorporeal Shock-wave, Urological (Class II - Special Controls, product code LNS).
Submitted by Shenzhen Wikkon Precision Technologies Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 18, 2025, 267 days after receiving the submission on September 24, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5990.
| 510(k) Number | K242922 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2024 |
| Decision Date | June 18, 2025 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LNS — Lithotriptor, Extracorporeal Shock-wave, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5990 |