K011178

Substantially Equivalent

WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR

Applicant: Wilson-Cook Medical, Inc.
Product code: LQC
Advisory panel: Gastroenterology, Urology
Date received: 2001-04-17
Decision date: 2001-05-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Winston-Salem, NC, US

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.