Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical

QPX · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4683

Classification

FDA Product Code: QPX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4683
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown