Cleared Traditional

K201472 - VenSure Balloon Device, VenSure Nav Balloon Device (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

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

K201472 is an FDA 510(k) clearance for the VenSure Balloon Device, VenSure Nav Balloon Device. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on August 26, 2020 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fiagon GmbH devices

Submission Details

510(k) Number K201472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 89d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.