QPX — Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical Class II
FDA product code QPX covers "Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical", a Class II medical device regulated under 21 CFR 878.4683. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QPX
- Device Class
- Class II
- Regulation Number
- 878.4683
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. Indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201400 | aatru medical | npSIMS Negative Pressure Surgical Incision Management System (npSIMS) | August 23, 2021 |