510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810291Substantially Equivalent

Sterile/disposable Hsg Tray

Unimar, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810291 is the FDA 510(k) clearance record for STERILE/DISPOSABLE HSG TRAY, a class II device, cleared for Unimar, Inc. on under FDA product code EYY (Drape, Urological, Disposable). FDA records list 10 510(k) clearances for Unimar, Inc., from to . As of , FDA records show no recalls naming K810291.

Clearance record

Decision date
Received
(43 days to decision)
Product code
EYY Drape, Urological, Disposable
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Unimar, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EYY

Trailing 12 months

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

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