Product Classification

• Device: enzyme packed cartridge
• Regulation Description: Enzyme packed cartridge.
• Definition: Hydrolyze fats in enteral formula.
• Physical State: Cartridge packed with enzyme linked beads
• Technical Method: Hydrolyzes fats in enteral formula ex vivo and delivers them into the enteral tract through a feeding tube
• Target Area: GI tract
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: PLQ
• Premarket Review: Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A); Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
• Submission Type: 510(k)
• Regulation Number: 876.5985
• 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