K011700

Substantially Equivalent

MODULITH SLK LITHOTRIPTER

Applicant: Karl Storz Endoscopy
Product code: LNS
Advisory panel: Gastroenterology, Urology
Date received: 2001-06-01
Decision date: 2002-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

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.