510(k) K881680— ACKRAD H/S PROCEDURE TRAY

Unknown

Ackrad Laboratories

Clearance details

Applicant: Ackrad Laboratories
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1988-04-19
Decision date: 1988-07-15
Decision: Unknown
Clearance type: Traditional
Location: Cranford, NJ, US

Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.