DeviceClearance

K253972

Substantially Equivalent

IMAGE1 (TC400US); X-to-4U Adapter (TC040)

Applicant
Karl Storz SE & CO. KG
Product code
OWN
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tuttlingen, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code OWN

product code OWN
Malfunction
1,286
Total
1,286

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.