DeviceClearance

K822535

Substantially Equivalent

CIDEX*DIALYZER DISINFECTING SOLUTION

Applicant
Surgikos, Inc.
Product code
FKQ
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fort Worth, TX, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FKQ

product code FKQ
Other
1
Total
1

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.