QPX · Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
General, Plastic Surgery · 21 CFR 878.4683 · Class 2
Overview
| Product Code | QPX |
|---|---|
| Device Name | Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical |
| Regulation | 21 CFR 878.4683 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.
Classification Rationale
Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201400 | npSIMS Negative Pressure Surgical Incision Management System (npSIMS) | Aatru Medical, LLC | Aug 23, 2021 | SESE |
Top Applicants
- Aatru Medical, LLC — 1 clearance
