IntraMarX Radiopaque Markers
K-Number: K191087 · 2019-12-18
ApplicantAnx Robotica Corp
Decision Date2019-12-18
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
IntraMarX Radiopaque Markers is a medical device manufactured by Anx Robotica Corp. It received FDA 510(k) clearance on 2019-12-18 under approval number K191087. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IntraMarX Radiopaque Markers?
IntraMarX Radiopaque Markers is a medical device that received FDA 510(k) clearance on 2019-12-18. It is manufactured by Anx Robotica Corp. The 510(k) number is K191087.
When was IntraMarX Radiopaque Markers approved by the FDA?
IntraMarX Radiopaque Markers received FDA 510(k) clearance on 2019-12-18, under approval number K191087.
What company makes IntraMarX Radiopaque Markers?
IntraMarX Radiopaque Markers is manufactured by Anx Robotica Corp.
What is the FDA product code for IntraMarX Radiopaque Markers?
The FDA product code for IntraMarX Radiopaque Markers is FFX.
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Related Devices (Code: FFX)
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.