510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PLQClass II

Enzyme Packed Cartridge

21 CFR 876.5985 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PLQ is the FDA product code for Enzyme Packed Cartridge, a class II device type, regulated under 21 CFR 876.5985. FDA's definition for this code reads: "Hydrolyze fats in enteral formula". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PLQ
Device name
Enzyme Packed Cartridge
FDA definition
Hydrolyze fats in enteral formula.
Regulation
21 CFR 876.5985
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
8
Ingested recalls
0

Clearances, product code PLQ

By decision year
8 clearances under product code PLQ with a decision year between 2015 and 2025, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PLQ by decision year
YearClearances
20151
20161
20171
20191
20232
20252

Applicants with the most clearances

Product code PLQ
Applicants holding the most 510(k) clearances under product code PLQ
ApplicantClearances
Alcresta Therapeutics, Inc.7
Alcresta, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code