Cleared Special

K131709 - SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K131709 · Arthrocare Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
115d
Days
Class 1
Risk

K131709 is an FDA 510(k) clearance for the SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Arthrocare Corp. (Austin, US). The FDA issued a Cleared decision on October 4, 2013 after a review of 115 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arthrocare Corp. devices

Submission Details

510(k) Number K131709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2013
Decision Date October 04, 2013
Days to Decision 115 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 89d · This submission: 115d
Pathway characteristics
Modification to existing cleared device.

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.