K242922
- 510(k) number
- K242922
- Device name
- Extracorporeal Shock Wave Lithotripter (U200)
- Applicant
- Shenzhen Wikkon Precision Technologies Co., Ltd. CN
- Product code
- LNS — Lithotriptor, Extracorporeal Shock-Wave, Urological
- Decision date
- 2025-06-18
- Date received
- 2024-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242922.pdf
Official FDA record: K242922
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.