FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Enzyme Packed Cartridge - RELiZORB
K Number: K231156
·
Decision Aug 30, 2023
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
7
Applicant Total
7
Review Days
128
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Basic Information
- Device Name
- Enzyme Packed Cartridge - RELiZORB
- K Number
- K231156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5985
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alcresta Therapeutics, Inc.
- Date Received
- April 24, 2023
- Decision Date
- August 30, 2023
- Product Code
- PLQ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PLQ | Enzyme Packed Cartridge | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PLQ), ordered by most recent decision date.
RELiZORB (100300/100301)
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FDA 510(k)
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Other Clearances by Alcresta Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250499 | RELiZORB (100300/100301) | Apr 17, 2025 | Substantially Equivalent |
| K243284 | RELiZORB (100300/ 100301) | Jan 15, 2025 | Substantially Equivalent |
| K232784 | RELiZORB® | Dec 21, 2023 | Substantially Equivalent |
| K191379 | RELiZORB | Dec 4, 2019 | Substantially Equivalent |
| K163057 | Relizorb | Jul 12, 2017 | Substantially Equivalent |
| K161247 | Relizorb | Jun 30, 2016 | Substantially Equivalent |