Cleared Traditional

K161698 - Relieva UltirraNav Sinus Balloon Catheter (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K161698 · Acclarent, Inc. · Ear, Nose, Throat device
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Oct 2016
Decision
126d
Days
Class 1
Risk

K161698 is an FDA 510(k) clearance for the Relieva UltirraNav Sinus Balloon Catheter. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Acclarent, Inc. (Irvin, US). The FDA issued a Cleared decision on October 24, 2016 after a review of 126 days - within the typical 510(k) review window.

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 Acclarent, Inc. devices

Submission Details

510(k) Number K161698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2016
Decision Date October 24, 2016
Days to Decision 126 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
37d slower than avg
Panel avg: 89d · This submission: 126d
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 64
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K161698.
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