KARL STORZ TELESCOPE BRIDGES AND ADAPTERS— 510(k) K945527

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K945527 for KARL STORZ TELESCOPE BRIDGES AND ADAPTERS, Substantially Equivalent on 1994-12-23. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 1994-11-10
Decision date: 1994-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.