Reia PP01-3
by Reia, LLC
Reia PP01-3 is a pelvic-organ-supporting pessary (FDA Class II; FDA product code HHW, Pessary, Vaginal) made by Reia, LLC, cleared under FDA 510(k) K232677 on 21 May 2024 and listed in FDA GUDID since 22 Jul 2024 (UDI-DI 00860012119325), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00860012119325 | Date22 Jul 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232677 | Date21 May 2024 | StatusActive |
Official records
- AccessGUDID record 00860012119325
- FDA 510(k) database K232677
Across registries
- FDA 510(k) K232677 decided 21 May 2024 Active
- FDA GUDID UDI-DI 00860012119325 listed 22 Jul 2024 Listed
Timeline
- Cleared FDA 510(k) K232677
- Listed FDA GUDID 00860012119325
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Reia
- Generic name
- Pelvic-organ-supporting pessary
- Model / reference
- PP01-3
- Primary DI / UDI-DI
- 00860012119325
- 510(k) Number
- FDA product code
- HHW
- GMDN term
- Pelvic-organ-supporting pessary
- Device class
- Class II
- Regulation number
- 884.3575
- GUDID distribution status
- In Commercial Distribution
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