11274 AC FLEXINBLE CHOLEDOCHOSCOPE— 510(k) K931382

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K931382 for 11274 AC FLEXINBLE CHOLEDOCHOSCOPE, Substantially Equivalent on 1993-06-18. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code FBN
Advisory panel: Gastroenterology, Urology
Date received: 1993-03-18
Decision date: 1993-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

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.