FDA 510(k)

OWL RF INSULATED CANNULAE

K-Number: K170708 · 2017-06-27

Decision Date2017-06-27

Product CodeGXI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

OWL RF INSULATED CANNULAE is a medical device manufactured by Diros Technology, Inc.. It received FDA 510(k) clearance on 2017-06-27 under approval number K170708. 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 OWL RF INSULATED CANNULAE?

OWL RF INSULATED CANNULAE is a medical device that received FDA 510(k) clearance on 2017-06-27. It is manufactured by Diros Technology, Inc.. The 510(k) number is K170708.

When was OWL RF INSULATED CANNULAE approved by the FDA?

OWL RF INSULATED CANNULAE received FDA 510(k) clearance on 2017-06-27, under approval number K170708.

What company makes OWL RF INSULATED CANNULAE?

OWL RF INSULATED CANNULAE is manufactured by Diros Technology, Inc..

What is the FDA product code for OWL RF INSULATED CANNULAE?

The FDA product code for OWL RF INSULATED CANNULAE is GXI.

Related Devices (Code: 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.