SOEHENDRA LITHOTRIPSY SET— 510(k) K902170

Substantially Equivalent

Wilson-Cook Medical, Inc.

FDA 510(k) clearance K902170 for SOEHENDRA LITHOTRIPSY SET, Substantially Equivalent on 1990-07-25. Applicant: Wilson-Cook Medical, Inc..

Clearance details

Applicant: Wilson-Cook Medical, Inc.
Product code: Code LQC
Advisory panel: Gastroenterology, Urology
Date received: 1990-05-14
Decision date: 1990-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LQC

product code LQC

Death: 7
Injury: 247
Malfunction: 956
Total: 1,210

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.