Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
The Negative Pressure Wound Therapy Non-Powered Suction Pump (Chemical) is a wound management device that applies continual or intermittent negative pressure to wounds for the removal of fluids including wound exudate, irrigation fluids, and infectious materials. It is indicated for management of chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers, flaps, and grafts. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 878.4683 in the General and Plastic Surgery specialty. It carries product code QPX and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QPX
- Device Class
- FDA class 2
- Regulation Number
- 878.4683
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K201400 | npSIMS Negative Pressure Surgical Incision Management System (npSIMS) | Aug 23, 2021 | Substantially Equivalent | Aatru Medical, LLC |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.