DeviceClearance

K241945

Substantially Equivalent

KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)

Applicant
Karl Storz SE & CO. KG
Product code
FGB
Advisory panel
Gastroenterology, Urology
Date received
Decision date
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, through . 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.