Legacy

FDA 510(k) K252696 · Phasor Health, LLC

Substantially Equivalent

510(k) numberK252696

Submission

Device name
Legacy
Applicant
Phasor Health, LLC
Houston, TX, US
Received
August 27, 2025
Decision date
November 21, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HBG – Drills, Burrs, Trephines & Accessories (Manual)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4300
Specialty
Neurology

Other 510(k)s with product code HBG

510(k)DeviceApplicantDecision
K153587Taps for Resorbable ScrewsHBG · Traditional Synthes (USA) Products, LLC01/18/2017SE
K162884SpineGuard DSG Zavation Screw SystemHBG · Traditional Spineguard S.A.01/12/2017SE
K160129MRII Cranial Drill and AccessoriesHBG · Special Mri Interventions, Inc.03/26/2016SE
K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmHBG · Special Mri Interventions, Inc.07/08/2015SE
K122456Mrii Crainial DrillHBG · Traditional Mri Interventions, Inc.03/22/2013SE
K022712Hand Drill, Model 11-9901-7HBG · Traditional Medical Design, LLC11/12/2002SE
K022370Framelock; Framelock AccessoriesHBG · Traditional Medtronic Xomed, Inc.10/18/2002SE
K961113CNS Interchangeable Bit Cranial DrillHBG · Traditional Clinical Neuro Systems, LLC06/05/1996SE
K932402Modification to Ghajar Guide Twist DrillHBG · Traditional Neurodynamics, Inc.08/05/1993SE
K915546PS Medical Ventriculostomy KitHBG · Traditional Pudenz-Schulte Medical Research Corp.12/30/1991SE

More from Pudenz-Schulte Medical Research Corp.

510(k)DeviceDecision
K252514Evac-MriJXG · Traditional 11/05/2025SESD
K252060GreenHBE · Traditional 10/31/2025SE
K250505Ez-FiducialsHAW · Traditional 07/09/2025SE
K243205EvacJXG · Traditional 06/03/2025SE

Questions and answers

When was Legacy cleared by the FDA?

Legacy (K252696) received a 510(k) decision of Substantially Equivalent on November 21, 2025, 86 days after the submission was received.

What is the product code of K252696?

The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.