Home / 510(k) Clearances / K161704

510(k) K161704

Phasor Drill by Biotex, Inc. — Product Code HBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2016
Date Received
June 20, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device Class
Class II
Regulation Number
882.4310
Review Panel
NE
Submission Type

Other clearances by Biotex, Inc.

  • K233442 — troCarWash™ System (May 21, 2024)
  • K222695 — troCarWash™ System (February 17, 2023)
  • K203712 — The Slide (July 20, 2021)
  • K092197 — PHOTEX30 DIODE LASER SERIES: 980, 810, 940 (October 6, 2009)
  • K081656 — VISUALASE THERMAL THERAPY SYSTEM (September 10, 2008)
  • K071328 — VISUALASE THERMAL THERAPY SYSTEM (August 31, 2007)
  • K063505 — VISUALASE ENVISION SOFTWARE SYSTEM (December 12, 2006)
  • K060304 — PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 (March 21, 2006)
  • K053087 — VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETE (March 1, 2006)

Other clearances for product code HBE

  • K250815 — Hubly Drill (H100) (November 6, 2025)
  • K252060 — GREEN (October 31, 2025)
  • K252662 — UniBur (September 19, 2025)
  • K251433 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070 (June 4, 2025)
  • K250380 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.0 (March 13, 2025)
  • K250374 — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision (March 11, 2025)
  • K232684 — Surgify Halo (November 29, 2023)
  • K230619 — Hubly Electric Drill (H100) (May 4, 2023)
  • K223199 — 2.1 x 255mm Drill, 22mm Stop (November 15, 2022)
  • K213072 — 2.1 x 255mm Drill, 22mm Stop (August 23, 2022)