ARIX Hand System
K-Number: K161746 · 2016-09-21
ApplicantJeil Medical Corporation
Decision Date2016-09-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ARIX Hand System is a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2016-09-21 under approval number K161746. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ARIX Hand System?
ARIX Hand System is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by Jeil Medical Corporation. The 510(k) number is K161746.
When was ARIX Hand System approved by the FDA?
ARIX Hand System received FDA 510(k) clearance on 2016-09-21, under approval number K161746.
What company makes ARIX Hand System?
ARIX Hand System is manufactured by Jeil Medical Corporation.
What is the FDA product code for ARIX Hand System?
The FDA product code for ARIX Hand System is HRS.
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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.