510(k) K161704 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Phasor Drill
| Applicant | Biotex, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Dec 1, 2016 |
| Received | Jun 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161704
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2025 | Phasor Health, LLC Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35 Open, Classified |
HBE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.