DeviceClearance

K020954

Substantially Equivalent

H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY

Applicant
Ackrad Laboratories
Product code
LKF
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Cranford, NJ, 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.