Cleared Traditional

Cranial Drill Bits and Accessories

K170442 · Ad-Tech Medical Instrument Corporation · Neurology
Sep 2017
Decision
205d
Days
Class 2
Risk

About This 510(k) Submission

K170442 is an FDA 510(k) clearance for the Cranial Drill Bits and Accessories, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Ad-Tech Medical Instrument Corporation (Racine, US). The FDA issued a Cleared decision on September 7, 2017, 205 days after receiving the submission on February 14, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K170442 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2017
Decision Date September 07, 2017
Days to Decision 205 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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