Cleared Traditional

LEGACY

K252696 · Phasor Health, LLC · Neurology
Nov 2025
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K252696 is an FDA 510(k) clearance for the LEGACY, a Drills, Burrs, Trephines & Accessories (manual) (Class II — Special Controls, product code HBG), submitted by Phasor Health, LLC (Houston, US). The FDA issued a Cleared decision on November 21, 2025, 86 days after receiving the submission on August 27, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4300.

Submission Details

510(k) Number K252696 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2025
Decision Date November 21, 2025
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBG — Drills, Burrs, Trephines & Accessories (manual)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4300

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