K890090

Substantially Equivalent

DANEK IRRIGATING BURR (DIB) SET

Applicant: Danek Medical, Inc.
Product code: GFF
Advisory panel: General, Plastic Surgery
Date received: 1989-01-10
Decision date: 1989-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Adverse events under product code GFF

product code GFF

Malfunction: 459
Other: 1
Total: 460

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.