CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION
Device Facts
| Record ID | K920677 |
|---|---|
| Device Name | CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION |
| Applicant | New Dimensions IN Medicine, Inc. |
| Product Code | NAE · General, Plastic Surgery |
| Decision Date | Apr 21, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4022 |
| Device Class | Class 1 |
Regulatory Classification
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.
