Cleared Traditional

K143738 - DSS Sinusplasty Balloon Catheter

K143738 is the FDA 510(k) clearance for DSS Sinusplasty Balloon Catheter by Intuit Medical Products, LLC. It is a Class 1 Ear, Nose, Throat device (product code LRC) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K143738 · Intuit Medical Products, LLC · Ear, Nose, Throat device
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Aug 2015
Decision
240d
Days
Class 1
Risk

K143738 is an FDA 510(k) clearance for the DSS Sinusplasty Balloon Catheter. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Intuit Medical Products, LLC (Sugar Hill, US). The FDA issued a Cleared decision on August 27, 2015 after a review of 240 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 Intuit Medical Products, LLC devices

Submission Details

510(k) Number K143738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2014
Decision Date August 27, 2015
Days to Decision 240 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
151d slower than avg
Panel avg: 89d · This submission: 240d
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 Peers - LRC Instrument, Ent Manual Surgical

All 25
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K143738.
Relieva SpinPlus Nav Balloon Sinuplasty System
K171687 · Acclarent, Inc. · Sep 2017
Relieva UltirraNav Sinus Balloon Catheter
K161698 · Acclarent, Inc. · Oct 2016
Relieva Scout Multi-Sinus Dilation System
K153341 · Acclarent, Inc. · Feb 2016
Relieva SpinPlus Balloon Sinuplasty System
K143541 · Acclarent, Inc. · Apr 2015
ACCLARENT SE Inflation Device
K150172 · Acclarent, Inc. · Apr 2015
RELIEVA SCOUT SINUS DILATION SYSTEM
K140160 · Acclarent, Inc. · Feb 2014