Product Classification

• Device: peripheral blood processing device for wound management
• Regulation Description: Automated blood cell separator.
• Definition: Preparation of autologous platelet rich plasma gel from a small sample of peripheral blood for wound management.
• Physical State: May include centrifuge and sterile single-use tubes and disposables
• Technical Method: Uses centrifugal methods to separate whole blood into components, after which the platelet rich plasma gel is withdrawn
• Target Area: Blood drawn from peripheral veins, PRP gel topically applied to exuding cutaneous wounds such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically-debrided wounds
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: PMQ
• Premarket Review: Center for Biologics Evaluation & Research (CBER)
• Submission Type: 510(k)
• Regulation Number: 864.9245
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible