DeviceClearance

K010056

Substantially Equivalent

UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450

Applicant
A & A Medical, Inc.
Product code
LKF
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alpharetta, GA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LKF

product code LKF
Malfunction
643
Other
2
Total
645

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.