K253411

Substantially Equivalent

Miniature Telescope for Urology (27033AA)

Applicant: Karl Storz SE & CO. KG
Product code: FGB
Advisory panel: Gastroenterology, Urology
Date received: 2025-09-30
Decision date: 2025-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

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.