RELiZORB
FDA 510(k) clearance K191379 · decided 2019-12-04
Clearance details
- K-number
- K191379
- Device name
- RELiZORB
- Applicant
- Alcresta Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-23
- Decision date
- 2019-12-04
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- PLQ
- Device class
- 2
- Regulation number
- 876.5985
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Newton, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RELiZORB (100300/100301) (K250499) | Alcresta Therapeutics, Inc. | 2025-04-17 |
| RELiZORB (100300/ 100301) (K243284) | Alcresta Therapeutics, Inc. | 2025-01-15 |
| RELiZORB® (K232784) | Alcresta Therapeutics, Inc. | 2023-12-21 |
| Enzyme Packed Cartridge - RELiZORB (K231156) | Alcresta Therapeutics, Inc. | 2023-08-30 |
| Relizorb (K163057) | Alcresta Therapeutics, Inc. | 2017-07-12 |
| Relizorb (K161247) | Alcresta Therapeutics, Inc. | 2016-06-30 |
| RELIZORB (DEN150001) | Alcresta, Inc. | 2015-11-20 |
Recalls involving this device
No recalls on record reference this clearance.