Cleared Traditional

SPIROX INEX DEVICE

K132920 · Spirox, Inc. · Ear, Nose, Throat

Jun 2014

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K132920 is an FDA 510(k) clearance for the SPIROX INEX DEVICE, a Polymer, Ear, Nose And Throat, Synthetic, Absorbable (Class II — Special Controls, product code NHB), submitted by Spirox, Inc. (Menlo Park, US). The FDA issued a Cleared decision on June 10, 2014, 266 days after receiving the submission on September 17, 2013. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K132920 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 17, 2013
Decision Date	June 10, 2014
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	NHB — Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.3620
Definition	Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeon To Conform To The Patient's Needs. This Generic Type Of Device Is Made Of Absorbable Synthetic Polymer Materials.