KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM— 510(k) K974391

Substantially Equivalent

Karl Storz Imaging, Inc.

FDA 510(k) clearance K974391 for KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM, Substantially Equivalent on 1998-01-30. Applicant: Karl Storz Imaging, Inc..

Clearance details

Applicant: Karl Storz Imaging, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1997-11-21
Decision date: 1998-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.