Cleared Traditional

K172179 - Chitogel Endoscopic Sinus Surgery Kit

K172179 is an FDA 510(k) clearance for Chitogel Endoscopic Sinus Surgery Kit, manufactured by Chitogel, Ltd.. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K172179 · Chitogel, Ltd. · Ear, Nose, Throat device
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Oct 2017
Decision
90d
Days
Class 1
Risk

K172179 is an FDA 510(k) clearance for the Chitogel Endoscopic Sinus Surgery Kit. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Chitogel, Ltd. (Dunedin, NZ). The FDA issued a Cleared decision on October 17, 2017 after a review of 90 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 Chitogel, Ltd. devices

FDA 510(k) Submission Details - K172179

510(k) Number K172179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2017
Decision Date October 17, 2017
Days to Decision 90 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 90d · This submission: 90d
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 Consultant

Regulatory Strategies, Inc.
Gregory Mathison

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LYA Splint, Intranasal Septal

All 37
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K172179.
ChitoZolve
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SPIWay Endonasal Access Guide
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HEMOPORE
K141816 · Polyganics B.V., · Oct 2014
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
K141704 · Medtronic, Inc. · Oct 2014