DeviceClearance

Product code PLQ— Gastroenterology, Urology

Relizorb

Classification name
Enzyme Packed Cartridge
Device class
Class 2
Regulation
21 CFR 876.5985
Advisory panel
Gastroenterology, Urology
Total cleared
8
First cleared
Most recent

FDA classification definition

“Hydrolyze fats in enteral formula.”

— U.S. Food and Drug Administration, device classification record for product code PLQ under 21 CFR 876.5985, via openFDA

Market context for product code PLQ

FDA has cleared 8 devices under product code PLQ between 2015 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PLQ

Recent clearances under product code PLQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.