NAC · Dressing, Wound, Hydrophilic
General, Plastic Surgery · 21 CFR 878.4018 · Class 1
Overview
| Product Code | NAC |
|---|---|
| Device Name | Dressing, Wound, Hydrophilic |
| Regulation | 21 CFR 878.4018 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K082208 | DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER | Scivolutions, Inc. | Dec 1, 2008 | SESE |
| K925841 | HYDRASORB JOYCE SPONGE | Avitar, Inc. | May 12, 1993 | SESE |
| K914779 | ALGINATE FIBER | Adri/Technam | Dec 4, 1991 | SESE |
| K914575 | SORBSAN TOPICAL WOUND DRESSING (MODIFIED) | Dow B. Hickam, Inc. | Dec 4, 1991 | SESE |
Top Applicants
- Scivolutions, Inc. — 1 clearance
- Dow B. Hickam, Inc. — 1 clearance
- Avitar, Inc. — 1 clearance
- Adri/Technam — 1 clearance
