Cleared Special

K161191 - Latera Absorbable Nasal Implant

K161191 is an FDA 510(k) clearance for Latera Absorbable Nasal Implant, manufactured by Spirox, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code NHB cleared through the Special 510(k) pathway after a 57-day FDA review.

K161191 · Spirox, Inc. · Ear, Nose, Throat device
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Jun 2016
Decision
57d
Days
Class 2
Risk

K161191 is an FDA 510(k) clearance for the Latera Absorbable Nasal Implant. 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 23, 2016 after a review of 57 days - a notably fast clearance 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. 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 Spirox, Inc. devices

FDA 510(k) Submission Details - K161191

510(k) Number K161191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2016
Decision Date June 23, 2016
Days to Decision 57 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
32d faster than avg
Panel avg: 89d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

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 K161191.
PosiSep EAR Fragmentable Ear Dressing
K210411 · Hemostasis, LLC · May 2022
LATERA Absorbable Nasal Implant System
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PuraSinus
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PDS PLATES
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K070886 · Medtronic, Inc. · Apr 2007
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
K012409 · Walter Lorenz Surgical, Inc. · Oct 2001