510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860459Substantially Equivalent

Unity Disposable Incontinent Brief

Bevan Medical, Inc., Rexdale, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860459 is the FDA 510(k) clearance record for UNITY DISPOSABLE INCONTINENT BRIEF, a class I device, cleared for Bevan Medical, Inc. on under FDA product code EYQ (Garment, Protective, For Incontinence). FDA records list 2 510(k) clearances for Bevan Medical, Inc., from to . As of , FDA records show no recalls naming K860459.

Clearance record

Decision date
Received
(20 days to decision)
Product code
EYQ Garment, Protective, For Incontinence
Regulation
21 CFR 876.5920
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Bevan Medical, Inc. 1 Greensboro Dr., Rexdale, CA
Third party review
No

Clearances, product code EYQ

Trailing 12 months

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

FDA records show no clearances under product code EYQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EYQ, 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