Cleared Traditional

Anchor Bolts as Accessories to Depth Electrodes

K223276 · Ad-Tech Medical Instrument Corporation · Neurology
May 2023
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K223276 is an FDA 510(k) clearance for the Anchor Bolts as Accessories to Depth Electrodes, a Electrode, Depth (Class II — Special Controls, product code GZL), submitted by Ad-Tech Medical Instrument Corporation (Oak Creek, US). The FDA issued a Cleared decision on May 18, 2023, 206 days after receiving the submission on October 24, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K223276 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2022
Decision Date May 18, 2023
Days to Decision 206 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZL — Electrode, Depth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1330

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