Cleared Traditional

ELAN 4 Electro Motor System Tools

K172709 · Aesculap, Inc. · Neurology
Oct 2018
Decision
404d
Days
Class 2
Risk

About This 510(k) Submission

K172709 is an FDA 510(k) clearance for the ELAN 4 Electro Motor System Tools, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on October 17, 2018, 404 days after receiving the submission on September 8, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K172709 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2017
Decision Date October 17, 2018
Days to Decision 404 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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