Cleared Special

ADVACOAT SINUS GEL AND STENT (K070496) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K070496 · Carbylan Biosurgery · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
23d
Days
Class 1
Risk

K070496 is an FDA 510(k) clearance for the ADVACOAT SINUS GEL AND STENT. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Carbylan Biosurgery (Palo Alto, US). The FDA issued a Cleared decision on March 15, 2007 after a review of 23 days - a notably fast clearance cycle.

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. 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 Carbylan Biosurgery devices

Submission Details

510(k) Number K070496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2007
Decision Date March 15, 2007
Days to Decision 23 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
66d faster than avg
Panel avg: 89d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 45
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K070496.
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SPIWay Endonasal Access Guide
K180141 · Spiway, LLC · Feb 2018