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FDA 510(k)

ELAN 4 Air Motor System

K-Number: K172907 · 2018-11-09

ApplicantAesculap, Inc.
Decision Date2018-11-09
Product CodeHBB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELAN 4 Air Motor System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K172907. The device is classified under product code HBB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELAN 4 Air Motor System?

ELAN 4 Air Motor System is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Aesculap, Inc.. The 510(k) number is K172907.

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

ELAN 4 Air Motor System received FDA 510(k) clearance on 2018-11-09, under 510(k) number K172907.

Who is the listed applicant for ELAN 4 Air Motor System?

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 Air Motor System?

The FDA product code for ELAN 4 Air Motor System is HBB.

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Official Source

View on FDA Database →

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

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