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

Wound Dressing Kit

21 CFR 880.5075 / General Hospital
FDA source (opens on fda.gov)

MCY is the FDA product code for Wound Dressing Kit, a class II device type, regulated under 21 CFR 880.5075. FDA's definition for this code 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 guidance above, is under enforcement discretion, and does not require a premarket...". As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 100 recalls.

Classification record

Product code
MCY
Device name
Wound Dressing Kit
FDA definition
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 guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Regulation
21 CFR 880.5075
Device class
Class II
Review panel
General Hospital
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
24
Ingested recalls
101

Clearances, product code MCY

By decision year
24 clearances under product code MCY with a decision year between 1990 and 1997, 1991 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code MCY by decision year
YearClearances
19901
199110
19936
19954
19962
19971

Applicants with the most clearances

Product code MCY
Applicants holding the most 510(k) clearances under product code MCY
ApplicantClearances
Catalina Biomedical Corp.2
Convatec, A Division of E.R. Squibb & Sons2
Medical Device Inspection Company2
Busse Hospital Disposables1
Continental Medical Laboratories, Inc.1
Customed, Inc1
Dermatological Research Laboratories, Inc.1
Ethicon, Inc1
Gesco Intl., Inc.1
Grand Medical Products1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 43 companies shown, in name order