The following data is part of a premarket notification filed by Biotex, Inc. with the FDA for Phasor Drill.
| Device ID | K161704 |
| 510k Number | K161704 |
| Device Name: | Phasor Drill |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | BIOTEX, INC. 114 HOLMES RD Houston, TX 77045 |
| Contact | Richard Waite |
| Correspondent | Manish Ahuja BIOTEX, INC. 114 HOLMES RD Houston, TX 77045 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-20 |
| Decision Date | 2016-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B775240L0 | K161704 | 000 |
| B775PH240210PHK20 | K161704 | 000 |
| B775PH240700 | K161704 | 000 |
| B775PH24070S0 | K161704 | 000 |
| B775PH2702100 | K161704 | 000 |
| B775PH270700 | K161704 | 000 |
| B775PH27070PHK10 | K161704 | 000 |
| B775PH27070PHK20 | K161704 | 000 |
| B775PH27070PHKA0 | K161704 | 000 |
| B775PH27070S0 | K161704 | 000 |
| B775PH27070SPHKA10 | K161704 | 000 |
| B775PH3202100 | K161704 | 000 |
| B775PH2402100 | K161704 | 000 |
| B775635K0 | K161704 | 000 |
| B775240S0 | K161704 | 000 |
| B775270K0 | K161704 | 000 |
| B775270L0 | K161704 | 000 |
| B775270S0 | K161704 | 000 |
| B775320L0 | K161704 | 000 |
| B7754500 | K161704 | 000 |
| B7755300 | K161704 | 000 |
| B775530K0 | K161704 | 000 |
| B7755800 | K161704 | 000 |
| B775580K0 | K161704 | 000 |
| B7756350 | K161704 | 000 |
| B775PH45070DPHK10 | K161704 | 000 |
| B775PH45070DPHKA0 | K161704 | 000 |
| B775PH45070DPHKA10 | K161704 | 000 |
| B775PH63570DPHKAS0 | K161704 | 000 |
| B775PH63570DTPHKA1S0 | K161704 | 000 |
| B775PH63570PHK10 | K161704 | 000 |
| B775PH63570PHK20 | K161704 | 000 |
| B775PH63570PHKA1S0 | K161704 | 000 |
| B775PH63570PHKAS0 | K161704 | 000 |
| B775PH635DT0 | K161704 | 000 |
| M710PH2402100 | K161704 | 000 |
| M710PH240700 | K161704 | 000 |
| M710PH2502100 | K161704 | 000 |
| M710PH2702100 | K161704 | 000 |
| B775PH63570DPHKA1S0 | K161704 | 000 |
| B775PH63570DPHKA0 | K161704 | 000 |
| B775PH45070DT0 | K161704 | 000 |
| B775PH45070DTPHKA10 | K161704 | 000 |
| B775PH45070PHK10 | K161704 | 000 |
| B775PH53070DPHK20 | K161704 | 000 |
| B775PH53070DPHKA0 | K161704 | 000 |
| B775PH53070DT0 | K161704 | 000 |
| B775PH53070DTPHKA1S0 | K161704 | 000 |
| B775PH580700 | K161704 | 000 |
| B775PH58070D0 | K161704 | 000 |
| B775PH635700 | K161704 | 000 |
| B775PH63570D0 | K161704 | 000 |
| M710PH270700 | K161704 | 000 |