FixxSure® X-Link
K-Number: K162143 · 2016-09-23
ApplicantInnovasis, Inc.
Decision Date2016-09-23
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FixxSure® X-Link is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2016-09-23 under approval number K162143. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FixxSure® X-Link?
FixxSure® X-Link is a medical device that received FDA 510(k) clearance on 2016-09-23. It is manufactured by Innovasis, Inc.. The 510(k) number is K162143.
When was FixxSure® X-Link approved by the FDA?
FixxSure® X-Link received FDA 510(k) clearance on 2016-09-23, under approval number K162143.
What company makes FixxSure® X-Link?
FixxSure® X-Link is manufactured by Innovasis, Inc..
What is the FDA product code for FixxSure® X-Link?
The FDA product code for FixxSure® X-Link is MNH. This falls under the ENT category.
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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.