FDA Product Code PLQ: Enzyme Packed Cartridge
Hydrolyze Fats In Enteral Formula.
Leading manufacturers include Alcresta Therapeutics, Inc..
FDA 510(k) Cleared Enzyme Packed Cartridge Devices (Product Code PLQ)
About Product Code PLQ - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PLQ since 2015, with 7 receiving FDA clearance (average review time: 150 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under PLQ have taken an average of 73 days to reach a decision - down from 176 days historically, suggesting improved FDA processing for this classification.
PLQ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →