Extracorporeal Shock Wave Lithotripter (U200)— 510(k) K242922
Substantially EquivalentShenzhen Wikkon Precision Technologies Co., Ltd.
FDA 510(k) clearance K242922 for Extracorporeal Shock Wave Lithotripter (U200), Substantially Equivalent on 2025-06-18. Applicant: Shenzhen Wikkon Precision Technologies Co., Ltd..
Clearance details
- Applicant
- Shenzhen Wikkon Precision Technologies Co., Ltd.
- Product code
- Code LNS
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Adverse events under product code LNS
product code LNS- Death
- 4
- Injury
- 320
- Total
- 324
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.