MODULITH SLK LITHOTRIPTER— 510(k) K011700

Name: FDA 510(k) clearance K011700
Creator: U.S. Food and Drug Administration
Published: 2002-08-16

Substantially Equivalent

Karl Storz Endoscopy

FDA 510(k) clearance K011700 for MODULITH SLK LITHOTRIPTER, Substantially Equivalent on 2002-08-16. Applicant: Karl Storz Endoscopy. Device class: 2.

Clearance details

Applicant: Karl Storz Endoscopy
Product code: Code LNS
Device class: Class 2
Regulation: 21 CFR 876.5990
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

Download summary PDF View on FDA.gov ↗

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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.