DeviceClearance

K022490

Substantially Equivalent

KSEA MEDI PACK

Applicant
KARL STORZ Endoscopy-America, Inc.
Product code
GCT
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Culver City, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GCT

product code GCT
Malfunction
1,393
Other
2
Total
1,395

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.