MSA · Dressing, Wound And Burn, Occlusive, Heated
General, Plastic Surgery · 21 CFR 878.4020 · Class 1
Overview
| Product Code | MSA |
|---|---|
| Device Name | Dressing, Wound And Burn, Occlusive, Heated |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K020077 | MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX | Augustine Medical, Inc. | Jan 31, 2002 | SESE |
| K963293 | AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX | Augustine Medical, Inc. | Mar 28, 1997 | SN |
Top Applicants
- Augustine Medical, Inc. — 2 clearances
