Cleared Traditional

Anchor Bolt (as an accessory to Depth Electrodes)

K181544 · Ad-Tech Medical Instrument Corporation · Neurology
Aug 2018
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K181544 is an FDA 510(k) clearance for the Anchor Bolt (as an accessory 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 August 9, 2018, 58 days after receiving the submission on June 12, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number K181544 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2018
Decision Date August 09, 2018
Days to Decision 58 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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