Phasor Drill
by Biotex, Inc.
510(k) K161704
Phasor Drill is a medical device (FDA Class II; FDA product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered)) made by Biotex, Inc., cleared under FDA 510(k) K161704 on 1 Dec 2016, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK161704 | Date1 Dec 2016 | StatusActive |
Official records
- FDA 510(k) database K161704
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
- Recall initiated FDA recalls Z-2192-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HBE
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4310
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K161704
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| PHASOR 2.70L | 2.70L / 2.70L | B775270L0 | — | On the market |
| PHASOR 5.30 | 5.30 / 5.30 | B7755300 | — | On the market |
| PHASOR 5.30K | 5.30K / 5.30K | B775530K0 | — | On the market |
| PHASOR 5.80 | 5.80 / 5.80 | B7755800 | — | On the market |
| PHASOR 6.35 | 6.35 / 6.35 | B7756350 | — | On the market |
| PHASOR PH-240-70-S | PH-240-70-S / PH-240-70-S | B775PH24070S0 | — | On the market |
| PHASOR PH-450-70-D + PH-K-1 | PH-450-70-D + PH-K-1 / PH-450-70-D + PH-K-1 | B775PH45070DPHK10 | — | On the market |
| PHASOR PH-635-70 | PH-635-70 / PH-635-70 | B775PH635700 | — | On the market |
| PHASOR PH-635-70 + PH-K-A1S | PH-635-70 + PH-K-A1S / PH-635-70 + PH-K-A1S | B775PH63570PHKA1S0 | — | On the market |
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