Phasor
Phasor GREEN Drill is a re-sterilizable drill driver (for use on one ore more patients, up to 10 total holes), with separately packaged single-use sterilized drill bit assembly -- for use…
Phasor GREEN Drill is a re-sterilizable drill driver (for use on one ore more patients, up to 10 total holes), with separately packaged single-use sterilized drill bit assembly — for use on adult patients during neurosurgical procedures for drilling of cranial bone. (This item contains the single-use sterilized drill bit assembly, whereby GRE.DBA.XXX indicates “XXX” as the drill bit designation.)
3manufacturers in China registered for this device type
80catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Phasor Health, LLC, United States |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K161704 |
| Record published | 2026-03-27 |
| Record revised | 2022-03-07 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Hydrogen Peroxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11.0L | In distribution | |
| PH-530-70-DT + PH-K-A1S | In distribution | |
| 2-IN-1-45K | In distribution | |
| 4-IN-1K | In distribution | |
| 2-IN-1K | In distribution | |
| 2.70L | In distribution | |
| PH-635-70-DT | In distribution | |
| 4-IN-1-2456K | In distribution | |
| 6.35K | In distribution | |
| PH-530-70-D + PH-K-2 | In distribution | |
| PH-635-70 + PH-K-AS | In distribution | |
| PH-580-70 | In distribution | |
| PH-635-70 + PH-K-A1S | In distribution | |
| 2-IN-1-45CK | In distribution | |
| GRE.DRI | In distribution | |
| PH-635-70-D + PH-K-2 | In distribution | |
| 5.80K | In distribution | |
| 14.0S | In distribution | |
| 6.35 | In distribution | |
| 3-IN-1-246K | In distribution | |
| PH-320-210 | In distribution | |
| 3-IN-1-45RK | In distribution | |
| 4.50K | In distribution | |
| PH-635-70 + PH-K-2 | In distribution | |
| 4.50L | In distribution | |
| 2-IN-1-05CK | In distribution | |
| 4.50 | In distribution | |
| PH-635-70 + PH-K-1 | In distribution | |
| PH-270-210 | In distribution | |
| PH-240-210 | In distribution | |
| PH-450-70-D + PH-K-A | In distribution | |
| PH-635-70 | In distribution | |
| PH-450-70-DT+PH-K-A1S | In distribution | |
| PH-450-70-DT | In distribution | |
| 5-IN-1 | In distribution | |
| PH-450-70-D + PH-K-A1 | In distribution | |
| 3-IN-1-256CK | In distribution | |
| PH-450-70-D + PH-K-1 | In distribution | |
| 3.20L | In distribution | |
| PH-530-70-D + PH-K-A | In distribution | |
| PH-530-70-DT | In distribution | |
| PH-270-70 + PH-K-1 | In distribution | |
| PH-270-70-S | In distribution | |
| PH-635-70-D + PH-K-A | In distribution | |
| 2-IN-1-25K | In distribution | |
| PH-240-70-S | In distribution | |
| PH-240-210 + PH-K-2 | In distribution | |
| 2.40L | In distribution | |
| PH-580-70-D | In distribution | |
| PH-635-70-D + PH-K-1 | In distribution | |
| PH-270-70 | In distribution | |
| 2-IN-1-26 | In distribution | |
| PH-635-70-D + PH-K-AS | In distribution | |
| PH-635-70-DT + PH-K-A1S | In distribution | |
| 14.0L | In distribution | |
| GRE.DBA | In distribution | |
| 5.30K | In distribution | |
| PH-240-70 | In distribution | |
| PH-450-70-DT + PH-K-A1 | In distribution | |
| PH-270-70 + PH-K-2 | In distribution | |
| PH-635-70-D | In distribution | |
| 2.70S | In distribution | |
| 11.0S | In distribution | |
| 5.80 | In distribution | |
| 8.40L | In distribution | |
| 2-IN-1 | In distribution | |
| PH-635-70-DT + PH-K-AS | In distribution | |
| 5-IN-1K | In distribution | |
| 3-IN-1-245K | In distribution | |
| 5.30 | In distribution | |
| PH-635-70-D + PH-K-A1S | In distribution | |
| PH-270-70-S + PH-K-A1 | In distribution | |
| 8.40S | In distribution | |
| 2.40S | In distribution | |
| 2.70K | In distribution | |
| 2.10L | In distribution | |
| PH-450-70 + PH-K-1 | In distribution | |
| 2-IN-1-26K | In distribution | |
| PH-530-70 + PH-K-2 | In distribution | |
| PH-270-70 + PH-K-A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midas REX MR8 | Medtronic Powered Surgical Solutions | 1,006 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker GmbH | 948 |
| Elan 4 | Aesculap AG | 529 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Synthes Gmbh | 514 |
| Zethon | Zethon Ltd | 237 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker Leibinger Gmbh & Co. KG | 220 |
| Midas Rex® | Medtronic Powered Surgical Solutions | 167 |
| HiCUT Burs | Adeor Medical AG | 90 |
| Traumaone System | Biomet Microfixation | 62 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 60 |
| Mids REX MR8 | Medtronic Powered Surgical Solutions | 59 |
| Midas Rex MR8 | Medtronic PS Medical | 59 |
Showing 12 of 269. All products under Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252060 | 2025-10-31 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Phasor Health, LLC | 510(k) number | 2025-03-21 | Class II | Process change control | Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time. | 1,064 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.