Flexible Video-Uretero-Choledochoscope System— 510(k) K142556

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K142556 for Flexible Video-Uretero-Choledochoscope System, Substantially Equivalent on 2014-10-23. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2014-09-11
Decision date: 2014-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

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.