FDA 510(k)

ELAN 4 Electro Motor System Tools

K-Number: K172709 · 2018-10-17

Decision Date2018-10-17

Product CodeHBE

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ELAN 4 Electro Motor System Tools is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2018-10-17 under 510(k) number K172709. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELAN 4 Electro Motor System Tools?

ELAN 4 Electro Motor System Tools is a medical device that received FDA 510(k) clearance on 2018-10-17. The listed applicant is Aesculap, Inc.. The 510(k) number is K172709.

When did ELAN 4 Electro Motor System Tools receive FDA 510(k) clearance?

ELAN 4 Electro Motor System Tools received FDA 510(k) clearance on 2018-10-17, under 510(k) number K172709.

Who is the listed applicant for ELAN 4 Electro Motor System Tools?

The FDA 510(k) record lists Aesculap, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELAN 4 Electro Motor System Tools?

The FDA product code for ELAN 4 Electro Motor System Tools is HBE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.