# K063308: Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200

- Pathway: 510(k) (Traditional)
- Applicant: Carbylan Biosurgery
- Decided: Dec 4, 2006 after 32 days
- Product code: LYA (Splint, Intranasal Septal)
- Device class: 1
- Regulation: 21 CFR 874.4780
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972082 (1997). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012532: Sepragel Sinus, Genzyme Corp. (2001) Summary page 1.
- K041381: Meropack Bioresorbable Nasal Packing and Sinus Stent, Medtronic Xomed, Inc. (2004) Summary page 1.
- K982731: Merogel Nasal Dressing and Sinus Stent, Xomed, Inc. (1999) Summary page 1.

## Most influential descendants
- K070496: Advacoat Sinus Gel and Stent (2007), 3 descendants of its own
- K092401: Sinexus Sinus Stent Gen 2, Model 1999-25 (2009), 1 descendant of its own
- K170913: Composite Removable Sinus Stent System (2017), 0 descendants of its own
- K160101: SinuBand (2016), 0 descendants of its own

## Indications for use
AdvaCoatTM Sinus Stent is intended for use in patients undergoing nasal/sinus surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces compromised by surgery or trauma, minimize edema and help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. AdvaCoatTM Sinus Gel is intended for use in patients undergoing nasal/sinus surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces compromised by surgery or trauma, minimize edema and help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process.

Source page: https://510kreport.com/device/K063308
Methodology: https://510kreport.com/methodology