Cleared Traditional

K132920 - SPIROX INEX DEVICE

K132920 is an FDA 510(k) clearance for SPIROX INEX DEVICE, manufactured by Spirox, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code NHB cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K132920 · Spirox, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
266d
Days
Class 2
Risk

K132920 is an FDA 510(k) clearance for the SPIROX INEX DEVICE. Classified as Polymer, Ear, Nose And Throat, Synthetic, Absorbable (product code NHB), Class II - Special Controls.

Submitted by Spirox, Inc. (Menlo Park, US). The FDA issued a Cleared decision on June 10, 2014 after a review of 266 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - 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 Spirox, Inc. devices

FDA 510(k) Submission Details - K132920

510(k) Number K132920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 89d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHB Device Classification - Class 2, Special Controls

Product Code NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable

All 9
Devices cleared under the same product code (NHB) and FDA review panel - the closest regulatory comparables to K132920.
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