Product Classification

• Device: hemostatic wound dressing without thrombin or other biologics
• Definition: To temporarily control bleeding and cover external wounds.
• Physical State: Commonly a solid sheet, powder form, or semi-solid form.
• Technical Method: Predominantly physical action, such as absorption of moisture from blood and thereby clumping the platelets, and by providing a tamponade effect.
• Target Area: Topical wounds
• Review Panel: General & Plastic Surgery
• Product Code: QSY
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); Plastic and Reconstructive Surgery Devices (DHT4B)
• Unclassified Reason: Pre-Amendment
• Submission Type: 510(k)
• Device Class: Unclassified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible