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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corp. It received FDA 510(k) clearance on 2019-12-18 under 510(k) 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. The listed applicant is Anx Robotica Corp. The 510(k) number is K191087.

When did IntraMarX Radiopaque Markers receive FDA 510(k) clearance?

IntraMarX Radiopaque Markers received FDA 510(k) clearance on 2019-12-18, under 510(k) number K191087.

Who is the listed applicant for IntraMarX Radiopaque Markers?

The FDA 510(k) record lists Anx Robotica Corp as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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