NAE · Dressing, Wound, Hydrogel Without Drug And/Or Biologic
General, Plastic Surgery · 21 CFR 878.4022 · Class 1
Overview
| Product Code | NAE |
|---|---|
| Device Name | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
| Regulation | 21 CFR 878.4022 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K083721 | MODIFICATION TO ZENIEVA | River'S Edge Pharmaceuticals, LLC | Jan 8, 2009 | SESE |
| K082865 | MODIFICATION TO ZENIEVA | Gorbec Pharmaceutical Services, Inc. | Oct 23, 2008 | SESE |
| K073246 | ZENIEVA | Gorbec Pharmaceutical Services, Inc. | Jul 23, 2008 | SESE |
| K992094 | GILTECH PLUS HYDROGEL SKIN DRESSING | Giltech Plus, Inc. | Sep 17, 1999 | SESE |
| K991061 | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING | Dermaphylyx, Inc. | Jun 28, 1999 | SESE |
| K972646 | AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES | Ludlow Technical Products | Aug 21, 1997 | SESE |
| K971597 | COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) | Coloplast Corp. | Jul 29, 1997 | SESE |
| K962352 | HYDROGEL SKIN DRESSING | North American Sterilization & Packaging Co. | Aug 2, 1996 | SESE |
| K952945 | AQUAFLO HYDROGEL WOUND DRESSING & PACKER | Sherwood Medical Co. | Aug 23, 1995 | SN |
| K951166 | BIODERM MEDICAL HYDROGEL ISLAND DRESSING | Bioderm, Inc. | Jun 21, 1995 | SESE |
| K950412 | CURAGEL HYDROGEL WOUND DRESSING | Kendall Healthcare Products Co. Div.Of Tyco Health | Mar 24, 1995 | SESE |
| K945832 | BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS | Brady Medical Products Co. | Mar 1, 1995 | SESE |
| K942748 | INTRASITE | Smith & Nephew United, Inc. | Jun 29, 1994 | SN |
| K941019 | BRADY MEDICAL PRODUCTS TRANSORBENTS WOUND DRESSING | Brady Medical Products Co. | May 4, 1994 | SN |
| K935848 | BRADY MEDICAL PRODUCTS TRANSORB WOUND DRESSING | Brady Medical Products Co. | Feb 15, 1994 | SN |
| K935705 | ALLEVYN ISLAND WOUND DRESSING | Smith & Nephew United, Inc. | Feb 15, 1994 | SESE |
| K934601 | NDM HYDROGAUZE WOUND DRESSING | Ndm Acquisition Corp. | Feb 15, 1994 | SESE |
| K932336 | NU-GEL ISLAND WOUND DRESSING | Johnson & Johnson Medical, Inc. | Feb 9, 1994 | SESE |
| K931618 | DUODERM HYDROCOLLOID GEL | Convatec, A Division of E.R. Squibb & Sons | Dec 10, 1993 | SESE |
| K926508 | INTRASITE GEL | Smith & Nephew United, Inc. | Jul 13, 1993 | SESE |
Top Applicants
- Brady Medical Products Co. — 4 clearances
- Smith & Nephew United, Inc. — 3 clearances
- Ndm Acquisition Corp. — 2 clearances
- Medtronic Vascular — 2 clearances
- Gorbec Pharmaceutical Services, Inc. — 2 clearances
