IRRAflow CNS System
K-Number: K171880 · 2018-07-13
ApplicantIrras, Inc.
Decision Date2018-07-13
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
IRRAflow CNS System is a medical device manufactured by Irras, Inc.. It received FDA 510(k) clearance on 2018-07-13 under approval number K171880. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IRRAflow CNS System?
IRRAflow CNS System is a medical device that received FDA 510(k) clearance on 2018-07-13. It is manufactured by Irras, Inc.. The 510(k) number is K171880.
When was IRRAflow CNS System approved by the FDA?
IRRAflow CNS System received FDA 510(k) clearance on 2018-07-13, under approval number K171880.
What company makes IRRAflow CNS System?
IRRAflow CNS System is manufactured by Irras, Inc..
What is the FDA product code for IRRAflow CNS System?
The FDA product code for IRRAflow CNS System is JXG.
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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.