Cleared Traditional

ELAN 4 Tools

K183203 · Aesculap, Inc. · Neurology
Aug 2019
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K183203 is an FDA 510(k) clearance for the ELAN 4 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 August 9, 2019, 263 days after receiving the submission on November 19, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K183203 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2018
Decision Date August 09, 2019
Days to Decision 263 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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