Cleared Traditional

RELIEVA SPIN SINUS DILATION SYSTEM (K111875) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K111875 · Acclarent, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Oct 2011
Decision
102d
Days
Class 1
Risk

K111875 is an FDA 510(k) clearance for the RELIEVA SPIN SINUS DILATION SYSTEM. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on October 11, 2011 after a review of 102 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 K111875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2011
Decision Date October 11, 2011
Days to Decision 102 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
13d slower than avg
Panel avg: 89d · This submission: 102d
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
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