KARL STORZ 3D VIDEO SYSTEM— 510(k) K001362

Substantially Equivalent

Karl Storz Imaging, Inc.

FDA 510(k) clearance K001362 for KARL STORZ 3D VIDEO SYSTEM, Substantially Equivalent on 2000-07-17. Applicant: Karl Storz Imaging, Inc..

Clearance details

Applicant: Karl Storz Imaging, Inc.
Product code: Code GCI
Advisory panel: Gastroenterology, Urology
Date received: 2000-04-28
Decision date: 2000-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

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Adverse events under product code GCI

product code GCI

Malfunction: 635
Total: 635

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.