Cleared Traditional

Sinusway Dilation System (K181838) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K181838 · 3nt Medical , Ltd. · Ear, Nose, Throat device
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Dec 2018
Decision
163d
Days
Class 1
Risk

K181838 is an FDA 510(k) clearance for the Sinusway Dilation System. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by 3nt Medical , Ltd. (Rosh Ha'Ayin, IL). The FDA issued a Cleared decision on December 20, 2018 after a review of 163 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all 3nt Medical , Ltd. devices

Submission Details

510(k) Number K181838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2018
Decision Date December 20, 2018
Days to Decision 163 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 89d · This submission: 163d
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.

Regulatory Consultant

Orly Maor
Orly Maor

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LRC Instrument, Ent Manual Surgical

All 11
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K181838.
VenSure Balloon Device, VenSure Nav Balloon Device
K201472 · Fiagon GmbH · Aug 2020
Dillard Nasal Balloon Catheter
K181546 · Intuit Medical Products, LLC · Jan 2020
RELIEVA ULTIRRA Sinus Balloon Catheter
K190525 · Acclarent, Inc. · May 2019
SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
K131709 · Arthrocare Corp. · Oct 2013
DISPOSABLE NASAL SCISSOR
K942063 · United States Surgical, A Division of Tyco Healthc · Jun 1994
DISPOSABLE NASAL RONGEUR
K942064 · United States Surgical, A Division of Tyco Healthc · Jun 1994