Cleared Traditional

GREEN

K252060 · Phasor Health, LLC · Neurology
Oct 2025
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K252060 is an FDA 510(k) clearance for the GREEN, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Phasor Health, LLC (Houston, US). The FDA issued a Cleared decision on October 31, 2025, 122 days after receiving the submission on July 1, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K252060 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2025
Decision Date October 31, 2025
Days to Decision 122 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

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