Acclarent Pivot PVT0616NZ
Acclarent Pivot PVT0616NZ is a Class II device made by Acclarent, Inc., cleared under FDA 510(k) K201115 on 27 Aug 2020 and listed in FDA GUDID since 1 Oct 2020 (UDI-DI 20705031465609), active as of 23 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 | Number20705031465609 | Date1 Oct 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201115 | Date27 Aug 2020 | StatusActive |
Official records
- AccessGUDID record 20705031465609
- FDA 510(k) database K201115
Across registries
- FDA 510(k) K201115 decided 27 Aug 2020 Active
- FDA GUDID UDI-DI 20705031465609 listed 1 Oct 2020 Listed
Timeline
- Cleared FDA 510(k) K201115
- Listed FDA GUDID 20705031465609
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acclarent Pivot
- Generic name
- Eustachian catheter, single-use
- Model / Ref / Catalog
- PVT0616NZ
- Primary DI / UDI-DI
- 20705031465609
- 510(k) Number
- FDA product code
- PGW, LRC, PNZ
- GMDN term
- Eustachian catheter, single-use
- Device class
- Class II
- Regulation number
- 882.4560, 874.4420, 874.4180
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe