Cleared Traditional

VenSure Balloon Device, VenSure Nav Balloon Device

K201472 · Fiagon GmbH · Ear, Nose, Throat
Aug 2020
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K201472 is an FDA 510(k) clearance for the VenSure Balloon Device, VenSure Nav Balloon Device, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on August 26, 2020, 84 days after receiving the submission on June 3, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K201472 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2020
Decision Date August 26, 2020
Days to Decision 84 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LRC — Instrument, Ent Manual Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420

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