PXY · Irrigation Kit (Wounds)
General, Plastic Surgery · 21 CFR 878.4014 · Class 1
Overview
| Product Code | PXY |
|---|---|
| Device Name | Irrigation Kit (Wounds) |
| 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 (0 of 0)
No cleared devices on record.
