510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K910363Substantially Equivalent

Mega Dressing Change Kit

Megadyne Medical Products, Inc, Hauppauge NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910363 is the FDA 510(k) clearance record for MEGA DRESSING CHANGE KIT, a class II device, cleared for Megadyne Medical Products, 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 50 510(k) clearances for Megadyne Medical Products, Inc., from to . As of , FDA records show no recalls naming K910363.

Clearance record

Decision date
Received
(58 days to decision)
Product code
MCY Wound Dressing Kit
Regulation
21 CFR 880.5075
Device class
Class II
Review panel
General Hospital
Applicant
Megadyne Medical Products, Inc. 400 Oser Ave., Hauppauge NY
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