EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER— 510(k) K131817

Substantially Equivalent

Osmunda Medical Device Consulting Co., Ltd.

FDA 510(k) clearance K131817 for EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, Substantially Equivalent on 2014-09-26. Applicant: Osmunda Medical Device Consulting Co., Ltd..

Clearance details

Applicant: Osmunda Medical Device Consulting Co., Ltd.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2013-06-20
Decision date: 2014-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, Guangdong, CN

Download summary PDF View on FDA.gov ↗

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.