Cleared Traditional

VenSure LightGuide

K212774 · Intersect Ent. · Ear, Nose, Throat

Feb 2022

Decision

156d

Days

Class 1

Risk

About This 510(k) Submission

K212774 is an FDA 510(k) clearance for the VenSure LightGuide, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Intersect Ent. (Menlo Park, US). The FDA issued a Cleared decision on February 4, 2022, 156 days after receiving the submission on September 1, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K212774 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 01, 2021
Decision Date	February 04, 2022
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF