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FDA 510(k)

VenSure LightGuide

K-Number: K212774 · 2022-02-04

Decision Date2022-02-04
Product CodeLRC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VenSure LightGuide is a medical device manufactured by Intersect Ent.. It received FDA 510(k) clearance on 2022-02-04 under approval number K212774. The device is classified under product code LRC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VenSure LightGuide?

VenSure LightGuide is a medical device that received FDA 510(k) clearance on 2022-02-04. It is manufactured by Intersect Ent.. The 510(k) number is K212774.

When was VenSure LightGuide approved by the FDA?

VenSure LightGuide received FDA 510(k) clearance on 2022-02-04, under approval number K212774.

What company makes VenSure LightGuide?

VenSure LightGuide is manufactured by Intersect Ent..

What is the FDA product code for VenSure LightGuide?

The FDA product code for VenSure LightGuide is LRC.

Other Devices by Intersect Ent.

Related Devices (Code: LRC)

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.