Cleared Special

K061903 - RELIEVA SINUS BALLOON CATHETER

K061903 is an FDA 510(k) clearance for RELIEVA SINUS BALLOON CATHETER, manufactured by Acclarent, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LRC cleared through the Special 510(k) pathway after a 44-day FDA review.

K061903 · Acclarent, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
44d
Days
Class 1
Risk

K061903 is an FDA 510(k) clearance for the RELIEVA SINUS BALLOON CATHETER. 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 August 18, 2006 after a review of 44 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Acclarent, Inc. devices

FDA 510(k) Submission Details - K061903

510(k) Number K061903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2006
Decision Date August 18, 2006
Days to Decision 44 days
Submission Type Special
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
46d faster than avg
Panel avg: 90d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

LRC Device Classification - Class 1, General Controls

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 63
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K061903.
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
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