NAD · Dressing, Wound, Occlusive
General, Plastic Surgery · 21 CFR 878.4020 · Class 1
Overview
| Product Code | NAD |
|---|---|
| Device Name | Dressing, Wound, Occlusive |
| Regulation | 21 CFR 878.4020 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive 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 107)
Showing 20 most recent of 107 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K102403 | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | Sam Medical Products | Mar 3, 2011 | SESE |
| K091133 | APLION TOPICAL CARE SYSTEM | Aplion Medical,Llc | May 20, 2009 | SESE |
| K072560 | ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) | Teikoku Pharma USA, Inc. | Jun 17, 2008 | SESE |
| K080524 | CENTURION SORBAVIEW OTC | Tri-State Hospital Supply Corp. | Apr 23, 2008 | SESE |
| K060046 | DERMASTREAM | Enzysurge , Ltd. | Feb 27, 2006 | SESE |
| K043063 | OXYBAND WOUND DRESSING | Oxyband Technologies, Inc. | Mar 24, 2005 | SESE |
| K020781 | WET CHAMBER | Kinetic Concepts, Inc. | May 6, 2002 | SESE |
| K990530 | KERLIX MD ANTIMICROBIAL GAUZE DRESSING | The Kendall Company, L.P. | Jan 31, 2000 | SESE |
| K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 | Hospital Specialty Co. | Apr 12, 1999 | SESE |
| K964534 | OTOSILK OTOLOGICAL GRAFT DRESSING | Boston Medical Products, Inc. | Apr 9, 1997 | SESE |
| K960815 | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL | Dumex Medical Surgical Products, Ltd. | Apr 29, 1996 | SESE |
| K955863 | ALLDRESS MULTI LAYERED WOUND DRESSING | Molnlycke/Scott Health Care | Mar 13, 1996 | SN |
| K952203 | OTOSILK | Boston Medical Products, Inc. | Jul 31, 1995 | SESE |
| K930697 | MEDLINE STERILE GAUZE SPONGES | Medline Industries, Inc. | Jun 24, 1993 | SESE |
| K912022 | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES | Fraass Survival Systems, Inc. | Aug 2, 1991 | SESE |
| K905519 | MONTROSE DRESSING APPLICATORS | Olemunda Pty , Ltd. | Mar 6, 1991 | SESE |
| K901853 | MODIFIED LABELING FOR BIOCLUSIVE* TRANS FILM DRESS | Johnson & Johnson Medical, Inc. | Jan 28, 1991 | SESE |
| K901378 | TENSOPLUS LITE | Smith & Nephew United, Inc. | Jun 12, 1990 | SESE |
| K897156 | HYDRASORB(TM) | Avitar, Inc. | Feb 21, 1990 | SESE |
| K895654 | SORBEX(TM) SOFT SPONGE | Fountain Pharmaceuticals, Inc. | Feb 20, 1990 | SN |
Top Applicants
- Smith & Nephew, Inc. — 5 clearances
- Chesebrough-Pond'S U.S.A. Co. — 5 clearances
- The Bfgoodrich Co. — 4 clearances
- Fraass Survival Systems, Inc. — 4 clearances
- Dermatec, Inc. — 4 clearances
