Cleared Special

SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT

K131709 · Arthrocare Corp. · Ear, Nose, Throat
Oct 2013
Decision
115d
Days
Class 1
Risk

About This 510(k) Submission

K131709 is an FDA 510(k) clearance for the SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT, a Instrument, Ent Manual Surgical (Class I — General Controls, product code LRC), submitted by Arthrocare Corp. (Austin, US). The FDA issued a Cleared decision on October 4, 2013, 115 days after receiving the submission on June 11, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number K131709 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LRC — Instrument, Ent Manual Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4420

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