510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890090Substantially Equivalent

Danek Irrigating Burr (Dib) Set

Danek Medical, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890090 is the FDA 510(k) clearance record for DANEK IRRIGATING BURR (DIB) SET, a class I device, cleared for Danek Medical, Inc. on under FDA product code GFF (Bur, Surgical, General & Plastic Surgery). FDA records list 56 510(k) clearances for Danek Medical, Inc., from to . As of , FDA records show no recalls naming K890090.

Clearance record

Decision date
Received
(14 days to decision)
Product code
GFF Bur, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Danek Medical, Inc. 3092 Director'S Row, Memphis TN
Third party review
No

Clearances, product code GFF

Trailing 12 months

FDA records hold no clearances under product code GFF in the trailing twelve months.

FDA records show no clearances under product code GFF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GFF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260