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 the device name listed in this FDA 510(k) record. The listed applicant is Intersect Ent.. It received FDA 510(k) clearance on 2022-02-04 under 510(k) 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. The listed applicant is Intersect Ent.. The 510(k) number is K212774.

When did VenSure LightGuide receive FDA 510(k) clearance?

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

Who is the listed applicant for VenSure LightGuide?

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

What is the FDA product code for VenSure LightGuide?

The FDA product code for VenSure LightGuide is LRC.

Other records listing Intersect Ent. as applicant

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

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