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510(k) K252696

LEGACY by Phasor Health, LLC — Product Code HBG

K252696 is an FDA 510(k) premarket notification submitted by Phasor Health, LLC for the device "LEGACY". The FDA issued a decision of Substantially Equivalent on November 21, 2025. The device falls under product code HBG (Drills, Burrs, Trephines & Accessories (Manual)), a Class II device regulated under 21 CFR 882.4300. Phasor Health, LLC has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2025
Date Received
August 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Manual)
Device Class
Class II
Regulation Number
882.4300
Review Panel
NE
Submission Type

Other clearances by Phasor Health, LLC

  • K252514 — EVAC-MRI (November 5, 2025)
  • K252060 — GREEN (October 31, 2025)
  • K250505 — EZ-FIDUCIALS (July 9, 2025)
  • K243205 — EVAC (June 3, 2025)

Other clearances for product code HBG

  • K153587 — Taps for Resorbable Screws (January 18, 2017)
  • K162884 — SpineGuard DSG Zavation Screw System (January 12, 2017)
  • K160129 — MRII Cranial Drill and Accessories (March 26, 2016)
  • K151536 — SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (July 8, 2015)
  • K122456 — MRII CRAINIAL DRILL (March 22, 2013)
  • K022712 — HAND DRILL, MODEL 11-9901-7 (November 12, 2002)
  • K022370 — FRAMELOCK; FRAMELOCK ACCESSORIES (October 18, 2002)
  • K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILL (June 5, 1996)
  • K932402 — MODIFICATION TO GHAJAR GUIDE TWIST DRILL (August 5, 1993)
  • K915546 — PS MEDICAL VENTRICULOSTOMY KIT (December 30, 1991)

FDA data resources