FDA 510(k)

Rulo Radiofrequency Lesion Probe

K-Number: K190256 · 2019-03-08

Decision Date2019-03-08

Product CodeGXI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Rulo Radiofrequency Lesion Probe is a medical device manufactured by Epimed International, Inc.. It received FDA 510(k) clearance on 2019-03-08 under approval number K190256. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rulo Radiofrequency Lesion Probe?

Rulo Radiofrequency Lesion Probe is a medical device that received FDA 510(k) clearance on 2019-03-08. It is manufactured by Epimed International, Inc.. The 510(k) number is K190256.

When was Rulo Radiofrequency Lesion Probe approved by the FDA?

Rulo Radiofrequency Lesion Probe received FDA 510(k) clearance on 2019-03-08, under approval number K190256.

What company makes Rulo Radiofrequency Lesion Probe?

Rulo Radiofrequency Lesion Probe is manufactured by Epimed International, Inc..

What is the FDA product code for Rulo Radiofrequency Lesion Probe?

The FDA product code for Rulo Radiofrequency Lesion Probe is GXI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.