STORZ MODULITH, MODEL SLX-F2— 510(k) K040476

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K040476 for STORZ MODULITH, MODEL SLX-F2, Substantially Equivalent on 2004-08-26. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2004-02-24
Decision date: 2004-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

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.