KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE— 510(k) K942112

Substantially Equivalent

Karl Storz Endoscopy

FDA 510(k) clearance K942112 for KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE, Substantially Equivalent on 1995-02-28. Applicant: Karl Storz Endoscopy.

Clearance details

Applicant: Karl Storz Endoscopy
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 1994-05-02
Decision date: 1995-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

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Adverse events under product code FBN

product code FBN

Death: 8
Malfunction: 951
Total: 959

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.