PLQ — Enzyme Packed Cartridge Class II
FDA product code PLQ covers "Enzyme Packed Cartridge", a Class II medical device regulated under 21 CFR 876.5985. Submissions are reviewed by the Gastroenterology, Urology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PLQ
- Device Class
- Class II
- Regulation Number
- 876.5985
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Hydrolyze fats in enteral formula.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250499 | Alcresta Therapeutics | RELiZORB (100300/100301) | Apr 17, 2025 |
| K243284 | Alcresta Therapeutics | RELiZORB (100300/ 100301) | Jan 15, 2025 |
| K232784 | Alcresta Therapeutics | RELiZORB® | Dec 21, 2023 |
| K231156 | Alcresta Therapeutics | Enzyme Packed Cartridge - RELiZORB | Aug 30, 2023 |
| K191379 | Alcresta Therapeutics | RELiZORB | Dec 4, 2019 |
| K163057 | Alcresta Therapeutics | Relizorb | Jul 12, 2017 |
| K161247 | Alcresta Therapeutics | Relizorb | Jun 30, 2016 |
| DEN150001 | Alcresta | RELIZORB | Nov 20, 2015 |