Varixis Elbow System
K-Number: K213014 · 2022-10-03
ApplicantAuxein Medical Private Limited
Decision Date2022-10-03
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Varixis Elbow System is a medical device manufactured by Auxein Medical Private Limited. It received FDA 510(k) clearance on 2022-10-03 under approval number K213014. 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 Varixis Elbow System?
Varixis Elbow System is a medical device that received FDA 510(k) clearance on 2022-10-03. It is manufactured by Auxein Medical Private Limited. The 510(k) number is K213014.
When was Varixis Elbow System approved by the FDA?
Varixis Elbow System received FDA 510(k) clearance on 2022-10-03, under approval number K213014.
What company makes Varixis Elbow System?
Varixis Elbow System is manufactured by Auxein Medical Private Limited.
What is the FDA product code for Varixis Elbow System?
The FDA product code for Varixis Elbow 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.