KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)— 510(k) K241945

Substantially Equivalent

Karl Storz SE & CO. KG

FDA 510(k) clearance K241945 for KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1), Substantially Equivalent on 2024-08-01. Applicant: Karl Storz SE & CO. KG.

Clearance details

Applicant: Karl Storz SE & CO. KG
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2024-07-03
Decision date: 2024-08-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Tuttlingen, DE

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.