ELAN 4 Tools
K-Number: K183203 · 2019-08-09
ApplicantAesculap, Inc.
Decision Date2019-08-09
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ELAN 4 Tools is a medical device manufactured by Aesculap, Inc.. It received FDA 510(k) clearance on 2019-08-09 under approval number K183203. 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 Tools?
ELAN 4 Tools is a medical device that received FDA 510(k) clearance on 2019-08-09. It is manufactured by Aesculap, Inc.. The 510(k) number is K183203.
When was ELAN 4 Tools approved by the FDA?
ELAN 4 Tools received FDA 510(k) clearance on 2019-08-09, under approval number K183203.
What company makes ELAN 4 Tools?
ELAN 4 Tools is manufactured by Aesculap, Inc..
What is the FDA product code for ELAN 4 Tools?
The FDA product code for ELAN 4 Tools is HBE.
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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.