Cleared Special

K070496 - ADVACOAT SINUS GEL AND STENT

K070496 is an FDA 510(k) clearance for ADVACOAT SINUS GEL AND STENT, manufactured by Carbylan Biosurgery. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Special 510(k) pathway after a 23-day FDA review.

K070496 · Carbylan Biosurgery · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K070496

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 90d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 37
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K070496.
SINEXUS SINUS STENT GEN 2, MODEL 1999-25
K092401 · Sinexus, Inc. · Nov 2009
SYNTHEMED DEVICE
K082276 · Synthemed, Inc. · Nov 2008
QUIKCLOT NOSEBLEED
K080247 · Z-Medica Corporation · Feb 2008
ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200
K063308 · Carbylan Biosurgery · Dec 2006
NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
K052099 · Polyganics B.V., · Nov 2005
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381 · Medtronic Xomed, Inc. · Sep 2004