PLQ

Enzyme Packed Cartridge

Product code
PLQ
Device name
Enzyme Packed Cartridge
Device class
Class 2
21 CFR
21 CFR 876.5985
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
8 (all years; only the last 3 years are listed here)

FDA classification definition

Hydrolyze fats in enteral formula.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-04-17.

NumberDecision dateApplicantDevice nameSummary
K2504992025-04-17Alcresta Therapeutics, Inc.RELiZORB (100300/100301)PDF
K2432842025-01-15Alcresta Therapeutics, Inc.RELiZORB (100300/ 100301)PDF
K2327842023-12-21Alcresta Therapeutics, Inc.RELiZORB®PDF

3 summaries are archived here for direct download.

Official FDA classification page: PLQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).