Cleared Traditional

K141816 - HEMOPORE

K141816 is an FDA 510(k) clearance for HEMOPORE, manufactured by Polyganics B.V.,. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K141816 · Polyganics B.V., · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Oct 2014
Decision
108d
Days
Class 1
Risk

K141816 is an FDA 510(k) clearance for the HEMOPORE. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Polyganics B.V., (Groningen, NL). The FDA issued a Cleared decision on October 23, 2014 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4780 - 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 Polyganics B.V., devices

FDA 510(k) Submission Details - K141816

510(k) Number K141816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2014
Decision Date October 23, 2014
Days to Decision 108 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
19d slower than avg
Panel avg: 89d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

LYA Device Classification - Class 1, General Controls

Product Code LYA Splint, Intranasal Septal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
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.

Regulatory Peers - LYA Splint, Intranasal Septal

All 19
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K141816.
Novapak Nasal Sinus Packing and Stent
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ChitoZolve
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SPIWay Endonasal Access Guide
K180141 · Spiway, LLC · Feb 2018
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
K141704 · Medtronic, Inc. · Oct 2014
ARTHROCARE NASASTENT CMC NASAL DRESSING
K140992 · ArthroCare Corporation · Jun 2014
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381 · Medtronic Xomed, Inc. · Sep 2004