Phasor Drill

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 United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K161704↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK161704	Date1 Dec 2016Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K161704

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-2192-2025 FDA Class II initiated 21 Mar 2025
Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

Timeline

2 dated events

1 Dec 2016 Cleared FDA 510(k) K161704
21 Mar 2025 Recall initiated FDA recalls Z-2192-2025

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K161704
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

59 devices · FDA GUDID

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.

Devices cleared under K161704
		UDI-DI	Size and differences
PHASOR 11.0L Phasor Health, LLC	11.0L	B775110L0	Prescription: no	On the market
PHASOR 11.0S Phasor Health, LLC	11.0S	B775110S0	Prescription: yes	On the market
PHASOR 14.0L Phasor Health, LLC	14.0L	B775140L0	Prescription: yes	On the market
PHASOR 14.0S Phasor Health, LLC	14.0S	B775140S0	Prescription: yes	On the market
PHASOR 2-IN-1 Phasor Health, LLC	2-IN-1 / 2-IN-1	B7752IN10	Prescription: yes	On the market
PHASOR 2-IN-1-26 Phasor Health, LLC	2-IN-1-26	B7752IN1260	Prescription: yes	On the market
PHASOR 2.10L Phasor Health, LLC	2.10L / 2.10L	B775210L0	Prescription: yes	On the market
PHASOR 2.40L Phasor Health, LLC	2.40L / 2.40L	B775240L0	Prescription: yes	On the market
PHASOR 2.40S Phasor Health, LLC	2.40S / 2.40S	B775240S0	Prescription: yes	On the market
PHASOR 2.70K Phasor Health, LLC	2.70K / 2.70K	B775270K0	Prescription: yes	On the market
PHASOR 2.70S Phasor Health, LLC	2.70S / 2.70S	B775270S0	Prescription: yes	On the market
PHASOR 3.20L Phasor Health, LLC	3.20L / 3.20L	B775320L0	Prescription: yes	On the market
PHASOR 4.50 Phasor Health, LLC	4.50 / 4.50	B7754500	Prescription: yes	On the market
PHASOR 4.50L Phasor Health, LLC	4.50L	B775450L0	Prescription: yes	On the market
PHASOR 5-IN-1 Phasor Health, LLC	5-IN-1 / 5-IN-1	B7755IN10	Prescription: yes	On the market
PHASOR 5.80K Phasor Health, LLC	5.80K / 5.80K	B775580K0	Prescription: yes	On the market
PHASOR 6.35K Phasor Health, LLC	6.35K / 6.35K	B775635K0	Prescription: yes	On the market
PHASOR 8.40L Phasor Health, LLC	8.40L	B775840L0	Prescription: yes	On the market
PHASOR 8.40S Phasor Health, LLC	8.40S	B775840S0	Prescription: yes	On the market
PHASOR PH-240-210 Phasor Health, LLC	PH-240-210 / PH-240-210	B775PH2402100	Prescription: yes	On the market
PHASOR PH-240-210 + PH-K-2 Phasor Health, LLC	PH-240-210 + PH-K-2 / PH-240-210 + PH-K-2	B775PH240210PHK20	Prescription: yes	On the market
PHASOR PH-240-70 Phasor Health, LLC	PH-240-70 / PH-240-70	B775PH240700	Prescription: yes	On the market
PHASOR PH-270-210 Phasor Health, LLC	PH-270-210 / PH-270-210	B775PH2702100	Prescription: yes	On the market
PHASOR PH-270-70 Phasor Health, LLC	PH-270-70 / PH-270-70	B775PH270700	Prescription: yes	On the market
PHASOR PH-270-70 + PH-K-1 Phasor Health, LLC	PH-270-70 + PH-K-1 / PH-270-70 + PH-K-1	B775PH27070PHK10	Prescription: yes	On the market
PHASOR PH-270-70 + PH-K-2 Phasor Health, LLC	PH-270-70 + PH-K-2 / PH-270-70 + PH-K-2	B775PH27070PHK20	Prescription: yes	On the market
PHASOR PH-270-70 + PH-K-A Phasor Health, LLC	PH-270-70 + PH-K-A / PH-270-70 + PH-K-A	B775PH27070PHKA0	Prescription: yes	On the market
PHASOR PH-270-70-S Phasor Health, LLC	PH-270-70-S / PH-270-70-S	B775PH27070S0	Prescription: yes	On the market
PHASOR PH-270-70-S + PH-K-A1 Phasor Health, LLC	PH-270-70-S + PH-K-A1 / PH-270-70-S + PH-K-A1	B775PH27070SPHKA10	Prescription: yes	On the market
PHASOR PH-320-210 Phasor Health, LLC	PH-320-210 / PH-320-210	B775PH3202100	Prescription: yes	On the market
PHASOR PH-450-70 + PH-K-1 Phasor Health, LLC	PH-450-70 + PH-K-1 / PH-450-70 + PH-K-1	B775PH45070PHK10	Prescription: yes	On the market
PHASOR PH-450-70-D + PH-K-A Phasor Health, LLC	PH-450-70-D + PH-K-A / PH-450-70-D + PH-K-A	B775PH45070DPHKA0	Prescription: yes	On the market
PHASOR PH-450-70-D + PH-K-A1 Phasor Health, LLC	PH-450-70-D + PH-K-A1 / PH-450-70-D + PH-K-A1	B775PH45070DPHKA10	Prescription: yes	On the market
PHASOR PH-450-70-DT Phasor Health, LLC	PH-450-70-DT / PH-450-70-DT	B775PH45070DT0	Prescription: yes	On the market
PHASOR PH-450-70-DT + PH-K-A1 Phasor Health, LLC	PH-450-70-DT + PH-K-A1	B775PH45070DTPHKA10	Prescription: yes	On the market
PHASOR PH-530-70-D + PH-K-2 Phasor Health, LLC	PH-530-70-D + PH-K-2	B775PH53070DPHK20	Prescription: yes	On the market
PHASOR PH-530-70-D + PH-K-A Phasor Health, LLC	PH-530-70-D + PH-K-A / PH-530-70-D + PH-K-A	B775PH53070DPHKA0	Prescription: yes	On the market
PHASOR PH-530-70-DT Phasor Health, LLC	PH-530-70-DT	B775PH53070DT0	Prescription: yes	On the market
PHASOR PH-530-70-DT + PH-K-A1S Phasor Health, LLC	PH-530-70-DT + PH-K-A1S / PH-530-70-DT + PH-K-A1S	B775PH53070DTPHKA1S0	Prescription: yes	On the market
PHASOR PH-580-70 Phasor Health, LLC	PH-580-70 / PH-580-70	B775PH580700	Prescription: yes	On the market
PHASOR PH-580-70-D Phasor Health, LLC	PH-580-70-D / PH-580-70-D	B775PH58070D0	Prescription: yes	On the market
PHASOR PH-635-70 + PH-K-1 Phasor Health, LLC	PH-635-70 + PH-K-1 / PH-635-70 + PH-K-1	B775PH63570PHK10	Prescription: yes	On the market
PHASOR PH-635-70 + PH-K-2 Phasor Health, LLC	PH-635-70 + PH-K-2 / PH-635-70 + PH-K-2	B775PH63570PHK20	Prescription: yes	On the market
PHASOR PH-635-70 + PH-K-AS Phasor Health, LLC	PH-635-70 + PH-K-AS / PH-635-70 + PH-K-AS	B775PH63570PHKAS0	Prescription: yes	On the market
PHASOR PH-635-70-D Phasor Health, LLC	PH-635-70-D / PH-635-70-D	B775PH63570D0	Prescription: yes	On the market
PHASOR PH-635-70-D + PH-K-A Phasor Health, LLC	PH-635-70-D + PH-K-A / PH-635-70-D + PH-K-A	B775PH63570DPHKA0	Prescription: yes	On the market
PHASOR PH-635-70-D + PH-K-A1S Phasor Health, LLC	PH-635-70-D + PH-K-A1S / PH-635-70-D + PH-K-A1S	B775PH63570DPHKA1S0	Prescription: yes	On the market
PHASOR PH-635-70-D + PH-K-AS Phasor Health, LLC	PH-635-70-D + PH-K-AS / PH-635-70-D + PH-K-AS	B775PH63570DPHKAS0	Prescription: yes	On the market
PHASOR PH-635-70-DT Phasor Health, LLC	PH-635-70-DT / PH-635-70-DT	B775PH635DT0	Prescription: yes	On the market
PHASOR PH-635-70-DT + PH-K-A1S Phasor Health, LLC	PH-635-70-DT + PH-K-A1S / PH-635-70-DT + PH-K-A1S	B775PH63570DTPHKA1S0	Prescription: yes	On the market

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Regulatory status

Recalls

Timeline

Coverage

Specification

Related clearances

Cites

Cited by

Devices cleared under K161704

Similar devices

Other devices from Biotex, Inc.

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Wire Watch™ WW-1D

Wire Watch™ WW-12K

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