Cleared Traditional

ELAN 4 Air Motor System

K172907 · Aesculap, Inc. · Neurology
Nov 2018
Decision
410d
Days
Class 2
Risk

About This 510(k) Submission

K172907 is an FDA 510(k) clearance for the ELAN 4 Air Motor System, a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 9, 2018, 410 days after receiving the submission on September 25, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K172907 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2017
Decision Date November 09, 2018
Days to Decision 410 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBB — Motor, Drill, Pneumatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4370

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