FDA 510(k)

kallisio stentra™ oral stent

K-Number: K232293 · 2023-12-22

Decision Date2023-12-22

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

kallisio stentra™ oral stent is the device name listed in this FDA 510(k) record. The listed applicant is Kallisio, Inc.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K232293. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the kallisio stentra™ oral stent?

kallisio stentra™ oral stent is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Kallisio, Inc.. The 510(k) number is K232293.

When did kallisio stentra™ oral stent receive FDA 510(k) clearance?

kallisio stentra™ oral stent received FDA 510(k) clearance on 2023-12-22, under 510(k) number K232293.

Who is the listed applicant for kallisio stentra™ oral stent?

The FDA 510(k) record lists Kallisio, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for kallisio stentra™ oral stent?

The FDA product code for kallisio stentra™ oral stent is IYE.

Related Devices (Code: IYE)

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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.