KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM— 510(k) K003325

Substantially Equivalent

Karl Storz Imaging, Inc.

FDA 510(k) clearance K003325 for KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM, Substantially Equivalent on 2001-04-27. Applicant: Karl Storz Imaging, Inc..

Clearance details

Applicant: Karl Storz Imaging, Inc.
Product code: Code FET
Advisory panel: Gastroenterology, Urology
Date received: 2000-10-24
Decision date: 2001-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

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Adverse events under product code FET

product code FET

Injury: 313
Malfunction: 54,276
Total: 54,589

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.