Product Code: NAE FDA class 1 21 CFR 878.4022

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

General, Plastic Surgery

The Hydrogel Wound Dressing Without Drug or Biologic is a wound care product composed of water-based hydrogel material that provides moisture to dry wounds, facilitates autolytic debridement, and maintains a moist wound healing environment without any incorporated drug or biological agent. Classified as FDA Class 1, it is subject to general controls under regulation 878.4022 (General and Plastic Surgery specialty).

View on FDA

510(k)s

FEI Numbers

292

Registration Numbers

292

Unique Applicants

Years Active

Research product code NAE in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: NAE
Device Class: FDA class 1
Regulation Number: 878.4022
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K083721	MODIFICATION TO ZENIEVA	Jan 08, 2009	Substantially Equivalent	River'S Edge Pharmaceuticals, LLC
K082865	MODIFICATION TO ZENIEVA	Oct 23, 2008	Substantially Equivalent	Gorbec Pharmaceutical Services, Inc.
K073246	ZENIEVA	Jul 23, 2008	Substantially Equivalent	Gorbec Pharmaceutical Services, Inc.
K992094	GILTECH PLUS HYDROGEL SKIN DRESSING	Sep 17, 1999	Substantially Equivalent	Giltech Plus, Inc.
K991061	DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING	Jun 28, 1999	Substantially Equivalent	Dermaphylyx, Inc.
K972646	AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES	Aug 21, 1997	Substantially Equivalent	Ludlow Technical Products
K971597	COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)	Jul 29, 1997	Substantially Equivalent	Coloplast Corp.
K962352	HYDROGEL SKIN DRESSING	Aug 02, 1996	Substantially Equivalent	North American Sterilization & Packaging Co.
K952945	AQUAFLO HYDROGEL WOUND DRESSING & PACKER	Aug 23, 1995	Substantially Equivalent for Some Indications	Sherwood Medical Co.
K951166	BIODERM MEDICAL HYDROGEL ISLAND DRESSING	Jun 21, 1995	Substantially Equivalent	Bioderm, Inc.
K950412	CURAGEL HYDROGEL WOUND DRESSING	Mar 24, 1995	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K945832	BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS	Mar 01, 1995	Substantially Equivalent	Brady Medical Products Co.
K942748	INTRASITE	Jun 29, 1994	Substantially Equivalent for Some Indications	Smith & Nephew United, Inc.
K941019	BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING	May 04, 1994	Substantially Equivalent for Some Indications	Brady Medical Products Co.
K935848	BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING	Feb 15, 1994	Substantially Equivalent for Some Indications	Brady Medical Products Co.
K935705	ALLEVYN ISLAND WOUND DRESSING	Feb 15, 1994	Substantially Equivalent	Smith & Nephew United, Inc.
K934601	NDM HYDROGAUZE WOUND DRESSING	Feb 15, 1994	Substantially Equivalent	Ndm Acquisition Corp.
K932336	NU-GEL ISLAND WOUND DRESSING	Feb 09, 1994	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K931618	DUODERM HYDROCOLLOID GEL	Dec 10, 1993	Substantially Equivalent	Convatec, A Division of E.R. Squibb & Sons
K926508	INTRASITE GEL	Jul 13, 1993	Substantially Equivalent	Smith & Nephew United, Inc.
K926202	CLEARSITE STERILE WOUND DRESSING, NDM WOUND DRESSI	May 12, 1993	Substantially Equivalent	Ndm Corp.
K922666	TRANSORB(TM) ULCER & WOUND DRESSING	Nov 23, 1992	Substantially Equivalent for Some Indications	Brady Medical Products Co.
K915359	PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH	May 28, 1992	Substantially Equivalent	Medtronic Vascular
K915357	PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH	May 28, 1992	Substantially Equivalent	Medtronic Vascular
K920677	CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION	Apr 21, 1992	Substantially Equivalent	New Dimensions IN Medicine, Inc.
K915182	DEROYAL HYDROGEL DRESSING	Apr 21, 1992	Substantially Equivalent	Deroyal Industries, Inc.
K914207	CLEARSITE(R) STERILE WOUND CARE DRESSING	Oct 23, 1991	Substantially Equivalent	Ndm Acquisition Corp.
K810902	IP-758 BURN WOUND DRESSING	Sep 11, 1981	Substantially Equivalent	Exopack
K802793	LOMATUELL OINTMENT DRESSING	Dec 18, 1980	Substantially Equivalent	Secol Co.