Flexible Video-Uretero-Renoscope SSU System— 510(k) K212458

Substantially Equivalent

Karl Storz Endoscopy America

FDA 510(k) clearance K212458 for Flexible Video-Uretero-Renoscope SSU System, Substantially Equivalent on 2022-01-20. Applicant: Karl Storz Endoscopy America.

Clearance details

Applicant: Karl Storz Endoscopy America
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2021-08-05
Decision date: 2022-01-20
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.