PLQClass II
Enzyme Packed Cartridge
Gastroenterology, Urology · 21 CFR 876.5985
Hydrolyze fats in enteral formula.
MDR events18All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances8All time
Recent MDR events
18 adverse event reports on file
- RELIZORBMay 27, 2026InjuryAlcresta Therapeutics, Inc.MW5188657
- RELIZORBMay 20, 2026InjuryUnkMW5188494
- RELIZORBMar 26, 2026InjuryAlcresta Therapeutics, Inc.MW5185939
- RELIZORBJan 8, 2026MalfunctionAlcresta Therapeutics, IncMW5181969
- RELIZORBAug 28, 2025MalfunctionAlcresta Therapeutics, Inc.MW5175329
- RELIZORBJan 29, 2025MalfunctionAlcresta Therapeutics, Inc.MW5165409
- RELIZORBNov 19, 2024MalfunctionAlcresta Therapeutics, Inc.20722797
- RELIZORB IMMOBILIZED LIPASE CARTRIDGESep 30, 2024InjuryAlcresta Therapeutics Inc.MW5160389
- RELIZORB IMMOBILIZED LIPASE CARTRIDGEAug 14, 2024MalfunctionAlcresta Therapeutics, Inc.MW5158473
- RELIZORB CARTRIDGEMay 18, 2021InjuryAlcresta Therapeutics, Inc.MW5101420
Event type breakdown
Injury12
Malfunction5
Unspecified1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Alcresta Therapeutics, Inc.Apr 17, 2025
K250499 · RELiZORB (100300/100301)
- Alcresta Therapeutics, Inc.Jan 15, 2025
K243284 · RELiZORB (100300/ 100301)
- Alcresta Therapeutics, Inc.Dec 21, 2023
K232784 · RELiZORB®
- Alcresta Therapeutics, Inc.Aug 30, 2023
K231156 · Enzyme Packed Cartridge - RELiZORB
- Alcresta Therapeutics, Inc.Dec 4, 2019
K191379 · RELiZORB
- Alcresta Therapeutics, Inc.Jul 12, 2017
K163057 · Relizorb
- Alcresta Therapeutics, Inc.Jun 30, 2016
K161247 · Relizorb
- Alcresta, Inc.Nov 20, 2015
DEN150001 · RELIZORB