510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952334Substantially Equivalent

Dressing Change Tray

Busse Hospital Disposables, Hauppauge NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952334 is the FDA 510(k) clearance record for DRESSING CHANGE TRAY, a class II device, cleared for Busse Hospital Disposables, 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 35 510(k) clearances for Busse Hospital Disposables, Inc., from to . As of , FDA records show no recalls naming K952334.

Clearance record

Decision date
Received
(57 days to decision)
Product code
MCY Wound Dressing Kit
Regulation
21 CFR 880.5075
Device class
Class II
Review panel
General Hospital
Applicant
Busse Hospital Disposables, Inc. 75 Arkay Dr., Hauppauge NY
510(k) summary
Summary
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