Extracorporeal Shock Wave Lithotripter (U200)— 510(k) K242922

Name: FDA 510(k) clearance K242922
Creator: U.S. Food and Drug Administration
Published: 2025-06-18

Substantially Equivalent

Shenzhen 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.. Device class: 2.

Clearance details

Applicant: Shenzhen Wikkon Precision Technologies Co., Ltd.
Product code: Code LNS
Device class: Class 2
Regulation: 21 CFR 876.5990
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-24
Decision date: 2025-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNS

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K261086 — Break Wave2026-04-29
K252913 — Break Wave2026-01-12
K221903 — Delta III Pro2023-02-22
K213772 — LM-9300 Plus Lithotripter2023-01-19
K201001 — Modulith SLX-F22021-03-30

Adverse events under product code LNS

product code LNS

Death: 4
Injury: 320
Total: 324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.