510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K912684Substantially Equivalent

Home Medical Kit - for Little Hurts

Great West Medical Equipment, Inc., West Vancouver, B.C., CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912684 is the FDA 510(k) clearance record for HOME MEDICAL KIT - FOR LITTLE HURTS, a class II device, cleared for Great West Medical Equipment, Inc. on under FDA product code MCY (Wound Dressing Kit). FDA's definition for product code MCY reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list one 510(k) clearance for Great West Medical Equipment, Inc. As of , FDA records show no recalls naming K912684.

Clearance record

Decision date
Received
(123 days to decision)
Product code
MCY Wound Dressing Kit
Regulation
21 CFR 880.5075
Device class
Class II
Review panel
General Hospital
Applicant
Great West Medical Equipment, Inc. 2081 Esquimalt Ave., West Vancouver, B.C., CA
510(k) summary
Statement
Third party review
No

Clearances, product code MCY

Trailing 12 months

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

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