510(k) K191379
- Device
- RELiZORB
- Applicant
- Alcresta Therapeutics, Inc.
- 510(k) number
- K191379
- Product code
- PLQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-12-04
- Date received
- 2019-05-23
- Regulation
- 876.5985
- Classification name
- Enzyme Packed Cartridge
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Eric First
- Address
- One Newton Executive Park Suite 100 Newton MA US 02462 02462
FDA Registration Numbers#
- 3007544634
- 3009596666
Source Documents#
Other 510(k) Records For Product Code PLQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250499 | RELiZORB (100300/100301) | Alcresta Therapeutics, Inc. | 2025-04-17 |
| K243284 | RELiZORB (100300/ 100301) | Alcresta Therapeutics, Inc. | 2025-01-15 |
| K232784 | RELiZORB® | Alcresta Therapeutics, Inc. | 2023-12-21 |
| K231156 | Enzyme Packed Cartridge - RELiZORB | Alcresta Therapeutics, Inc. | 2023-08-30 |
| K163057 | Relizorb | Alcresta Therapeutics, Inc. | 2017-07-12 |
| K161247 | Relizorb | Alcresta Therapeutics, Inc. | 2016-06-30 |
| DEN150001 | RELIZORB | Alcresta, Inc. | 2015-11-20 |
Legacy Summary#
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FDA Review#
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