Phasor Ph-270-70-S
Phasor Ph-270-70-S is a Class II device made by Phasor Health, LLC, cleared under FDA 510(k) K161704 on 1 Dec 2016 and listed in FDA GUDID since 7 Jun 2021 (UDI-DI B775PH27070S0), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB775PH27070S0 | Date7 Jun 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161704 | Date1 Dec 2016 | StatusActive |
Official records
- FDA 510(k) database K161704
Across registries
- FDA 510(k) K161704 decided 1 Dec 2016 Active
- FDA GUDID UDI-DI B775PH27070S0 listed 7 Jun 2021 Listed
Recalls
-
- Ongoing Z-2192-2025
Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.
Timeline
- Cleared FDA 510(k) K161704
- Listed FDA GUDID B775PH27070S0
- Recall initiated FDA recalls Z-2192-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Phasor
- Generic name
- Craniotomy power tool system, battery-powered, single-use
- Model / Ref / Catalog
- PH-270-70-S
- Primary DI / UDI-DI
- B775PH27070S0
- 510(k) Number
- FDA product code
- HBE
- GMDN term
- Craniotomy power tool system, battery-powered, single-use
- Device class
- Class II
- Regulation number
- 882.4310
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe