Cleared Traditional

ELAN 4 Electro Motor System

K203739 · Aesculap, Inc. · Neurology
Aug 2021
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K203739 is an FDA 510(k) clearance for the ELAN 4 Electro Motor System, 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 August 24, 2021, 245 days after receiving the submission on December 22, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K203739 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2020
Decision Date August 24, 2021
Days to Decision 245 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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