RECELL Autologous Cell Harvesting Device
PMA: BP170122
Tradename: RECELL Autologous Cell Harvesting Device
Manufacturer: Avita Medical Americas, LLC
Indication:
- The RECELL Autologous Cell Harvesting Device is indicated for the treatment of thermal burn wounds and full-thickness skin defects.
- The RECELL Device is used by an appropriately licensed and trained healthcare professional at the patient’s point of care to prepare autologous Spray-On Skin Cells for direct application to acute partial-thickness thermal burn wounds in patients 18 years of age and older, or application in combination with meshed autografting for acute full-thickness thermal burn wounds in pediatric and adult patients and full-thickness skin defects after traumatic avulsion (e.g., degloving) or surgical excision (e.g., necrotizing tissue infection) or resection (e.g., skin cancer) in patients 15 years of age and older.
Product Information
- Instructions for Use AW-IFU030 - RECELL Autologous Cell Harvesting Device
- Instructions for Use AW-IFU040 - RECELL Autologous Cell Harvesting Device
Supporting Documents
- June 7, 2023 Approval Letter - RECELL Autologous Cell Harvesting Device
- Summary of Safety and Effectiveness Data - RECELL Autologous Cell Harvesting Device
- Summary of Safety and Effectiveness - RECELL Autologous Cell Harvesting Device
- June 9, 2021 Approval Order - RECELL Autologous Cell Harvesting Device
- September 20, 2018 Approval Order - RECELL Autologous Cell Harvesting Device
- Summary of Safety and Effectiveness Data - RECELL Autologous Cell Harvesting Device