DANEK IRRIGATING BURR (DIB) SET— 510(k) K890090

Name: FDA 510(k) clearance K890090
Creator: U.S. Food and Drug Administration
Published: 1989-01-24

Substantially Equivalent

Danek Medical, Inc.

FDA 510(k) clearance K890090 for DANEK IRRIGATING BURR (DIB) SET, Substantially Equivalent on 1989-01-24. Applicant: Danek Medical, Inc.. Device class: 1.

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code GFF
Device class: Class 1
Regulation: 21 CFR 878.4820
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

Download summary PDF View on FDA.gov ↗

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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.