Product Code: MCY FDA class 2 21 CFR 880.5075

Wound Dressing Kit

General Hospital

The wound dressing kit is a general hospital convenience kit containing components for wound care and dressing application, assembled for ease of use in clinical settings; it falls under FDA enforcement discretion per the May 1997 convenience kits interim regulatory guidance. It is classified as FDA Class II under 21 CFR 880.5075 within the General Hospital specialty, requiring 510(k) premarket clearance. The product code is MCY and the device is not implanted. Full GMP compliance is required.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MCY
Device Class: FDA class 2
Regulation Number: 880.5075
Medical Specialty: General Hospital
Review Panel: SU
Submission Type: 7

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K970721	DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM	Mar 21, 1997	Substantially Equivalent for Some Indications	Johnson & Johnson Medical, Inc.
K963719	CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY	Nov 27, 1996	Substantially Equivalent	Grand Medical Products
K960585	WOUND CARE COMPRESSION SYSTEM (WCCS)	Apr 26, 1996	Substantially Equivalent	Suncoast Medical Products, Inc.
K952334	DRESSING CHANGE TRAY	Jul 14, 1995	Substantially Equivalent	Busse Hospital Disposables, Inc.
K951022	CIRCULON SYSTEM STEP 1	Jun 12, 1995	Unknown	Convatec, A Division of E.R. Squibb & Sons
K951021	CIRCULON SYSTEM STEP 2	Jun 12, 1995	Unknown	Convatec, A Division of E.R. Squibb & Sons
K951476	E-PACK PROCEDURE KITS	May 23, 1995	Unknown	ETHICON, Inc.
K931932	DRESSING CHANGE TRAY-MODIFIED	Aug 27, 1993	Unknown	Medsurg Industries, Inc.
K924690	VARIOUS NON-STERILE CUSTOM TRAYS/KITS	Jul 16, 1993	Unknown	Surgipro Central, Inc.
K923905	WOUND DRESSING KIT	Jul 02, 1993	Unknown	Kit Pak, Inc.
K926063	PER-Q-CATH DRESSING CHANGE TRAY	Jun 07, 1993	Unknown	Gesco Intl., Inc.
K925021	TPN TRAY (STERILE)	Jun 07, 1993	Unknown	Customed, Inc.
K921347	CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER	Jan 08, 1993	Unknown	Medi-Flex Hospital Products, Inc.
K913480	WOUND CARE TRAY A	Oct 18, 1991	Substantially Equivalent	Catalina Biomedical Corp.
K912116	PRESSURE SORE MANAGEMENT KIT	Oct 18, 1991	Substantially Equivalent	Medical Device Inspection Co., Inc.
K912684	HOME MEDICAL KIT - FOR LITTLE HURTS	Oct 15, 1991	Substantially Equivalent	Great West Medical Equipment, Inc.
K913479	WOUND CARE TRAY B	Oct 08, 1991	Substantially Equivalent	Catalina Biomedical Corp.
K912232	ULCERCARE	Aug 14, 1991	Substantially Equivalent	Jobst Institute, Inc.
K912117	LACERATION TRAY	Aug 09, 1991	Substantially Equivalent	Medical Device Inspection Co., Inc.
K910363	MEGA DRESSING CHANGE KIT	Mar 28, 1991	Substantially Equivalent	Megadyne Medical Products, Inc.
K910011	POST SURGICAL KIT/POST BIOPSY KIT	Mar 27, 1991	Substantially Equivalent	Dermatological Research Laboratories, Inc.
K905123	G-TUBE DRESSING CHANGE TRAY	Mar 27, 1991	Substantially Equivalent	Continental Medical Laboratories, Inc.
K905572	EDLICH WOUND MANAGEMENT TRAY	Mar 12, 1991	Unknown	Sorex Medical
K902811	ROUTINE DRESSING TRAY	Sep 25, 1990	Unknown	Orion Life Systems, Inc.