Cleared Traditional

ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200 (K063308) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K063308 · Carbylan Biosurgery · Ear, Nose, Throat device
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Dec 2006
Decision
32d
Days
Class 1
Risk

K063308 is an FDA 510(k) clearance for the ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200. 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 December 4, 2006 after a review of 32 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Carbylan Biosurgery devices

Submission Details

510(k) Number K063308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2006
Decision Date December 04, 2006
Days to Decision 32 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
57d faster than avg
Panel avg: 89d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

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 K063308.
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