EYF · Protector, Wound, Plastic
General, Plastic Surgery · 21 CFR 878.4014 · Class 1
Overview
| Product Code | EYF |
|---|---|
| Device Name | Protector, Wound, Plastic |
| Regulation | 21 CFR 878.4014 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K922785 | IRRIVAGE | Autovage | Oct 16, 1992 | SESE |
| K911407 | HARDING STERNAL SHIELD | Harding Medical Devices | Jul 5, 1991 | SESE |
| K910104 | ANTI-FOG DISPOSABLE IV INDUCTION COVER | Central Plastic, Inc. | Apr 12, 1991 | SESE |
| K904389 | SI-PRO | David F. Trungale | Dec 17, 1990 | SESE |
| K832908 | COMFEEL PROTECTIVE RINGS | Coloplast A/S | Dec 12, 1983 | SESE |
Top Applicants
- Harding Medical Devices — 1 clearance
- David F. Trungale — 1 clearance
- Coloplast A/S — 1 clearance
- Central Plastic, Inc. — 1 clearance
- Autovage — 1 clearance
