Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator

QCZ · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: QCZ
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: HE
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: Y
Implant: N
Third-party review: N

Definition

Intended to enable clinicians to prepare an autologous skin cell suspension for application to burn injuries for use when autografting is indicated for definitive wound closure.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 8

Source

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