510(k) Report

510(k) · Cleared

Cleared

Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200

K063308510(k) TraditionalCleared Dec 4, 200632-day reviewClass I21 CFR 874.4780

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Carbylan Biosurgery · LYA Splint, Intranasal Septal

Cleared on Dec 4, 2006 as substantially equivalent to K012532 (Genzyme Corp., 2001) and 2 other predicates after a 32-day review. Its family tree reaches back 2 generations to 1997. 4 later devices descend from it.

Decided
Dec 4, 2006
Review
32 days
Class
Class I
Product code
LYA
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K972082 (1997). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1999: 1 other ancestor2001: 1 other ancestor2007: 1 descendant cleared2016: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant clearedK972082 · Custom Nasal Splint · Boston Medical Products, Inc. · 1997K012532 · Sepragel Sinus · Genzyme Corp. · 20011995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant K012532 · Sepragel Sinus · Genzyme Corp. · 2001K972082 · Custom Nasal Splint · Boston Medical Products, Inc. · 19970
  1. Root · 2 generations backK972082 Custom Nasal SplintBoston Medical Products, Inc. · 1997
  2. 1 generation backK012532 Sepragel SinusGenzyme Corp. · 2001
  3. This deviceK063308 Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200Carbylan Biosurgery · 2006
  4. Descendant · cites it directly · 3 of its ownK070496 Advacoat Sinus Gel and StentCarbylan Biosurgery · 2007
  5. Descendant · 2 generations on · 1 of its ownK092401 Sinexus Sinus Stent Gen 2, Model 1999-25Sinexus, Inc. · 2009
  6. Descendant · 3 generations on · 0 of its ownK170913 Composite Removable Sinus Stent SystemSts Medical · 2017
  7. Descendant · 2 generations on · 0 of its ownK160101 SinuBandBioinspire Technologies, Incorporated · 2016

Most influential descendants

Showing 4 of 4 · See all
  • K070496Advacoat Sinus Gel and StentCarbylan Biosurgery · 2007 · cites it directly3descendants
  • K092401Sinexus Sinus Stent Gen 2, Model 1999-25Sinexus, Inc. · 2009 · 2 generations on1descendant
  • K170913Composite Removable Sinus Stent SystemSts Medical · 2017 · 3 generations on0descendants
  • K160101SinuBandBioinspire Technologies, Incorporated · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K972082Custom Nasal SplintBoston Medical Products, Inc.1997—
−1K012532Sepragel SinusGenzyme Corp.2001—
0 (this device)K063308Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200Carbylan Biosurgery2006—
+1K070496Advacoat Sinus Gel and StentCarbylan Biosurgery2007—
+2K092401Sinexus Sinus Stent Gen 2, Model 1999-25Sinexus, Inc.2009—
+3K170913Composite Removable Sinus Stent SystemSts Medical2017—
+2K160101SinuBandBioinspire Technologies, Incorporated2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200110
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201610
201710
FIG. 1 — Lineage of K063308, 1997–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LYA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LYA device

  1. #1 K243655 TurbAlignscore 10.0 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K012532Sepragel Sinus
Summary page 1
…21 CFR 874.4780 Product Code Number: LYA Performance Standards: No FDA performance standards exist for this product. Predicate Devices: Hyalsine Hylan B Gel (K012532) MeroPack (K041381) Merogel Nasal Dressing And Sinus Stent (K982731) Device Description: AdvaCoatTM Sinus Gel and Stent…
Genzyme Corp.2001—
*K041381Meropack Bioresorbable Nasal Packing and Sinus Stent
Summary page 1
…oduct Code Number: LYA Performance Standards: No FDA performance standards exist for this product. Predicate Devices: Hyalsine Hylan B Gel (K012532) MeroPack (K041381) Merogel Nasal Dressing And Sinus Stent (K982731) Device Description: AdvaCoatTM Sinus Gel and Stent (AdvaCoatTM) is a ste…
Medtronic Xomed, Inc.2004—
*K982731Merogel Nasal Dressing and Sinus Stent
Summary page 1
…FDA performance standards exist for this product. Predicate Devices: Hyalsine Hylan B Gel (K012532) MeroPack (K041381) Merogel Nasal Dressing And Sinus Stent (K982731) Device Description: AdvaCoatTM Sinus Gel and Stent (AdvaCoatTM) is a sterile, non-pyrogenic, non-swelling, viscoelastic,…
Xomed, Inc.1999—

Also cleared against K012532: 5 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070496Advacoat Sinus Gel and StentCarbylan Biosurgery20073

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K070496 (Carbylan Biosurgery, 2007) has gone furthest, with 3 descendants of its own.
  • 5 other devices also cite its predicate K012532.

How does its category compare?

All LYA devices

LYA Splint, Intranasal Septal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYA

1in 2025

2007: 12008: 22009: 12012: 12013: 22014: 52016: 12017: 22018: 22020: 12021: 12023: 12025: 1
2007high 5 (2014) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LYA

104in 2014

2014: 104 days median
2007high 104 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LYA

No recall names LYA since 2007.

Adverse event reports per year · LYA

1in 2025

2007: 22009: 52010: 22011: 162012: 162013: 12014: 42015: 282016: 282017: 102018: 192019: 52020: 62021: 192022: 82023: 172024: 72025: 1
2007high 28 (2015) · low 0 (2008)2025

MAUDE reports naming product code LYA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
20082—00
20091—05
20100—02
20110—016
20121—016
20132—01
2014510404
20150—028
20161—028
20172—010
20182—019
20190—05
20201—06
20211—019
20220—08
20231—017
20240—07
20251—01
20260—0—

What is it indicated for?

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…

Read the full statement (114 words)

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.

Indications for use as stated in the FDA summary.

Also cleared against K012532

5 other devices cite the same predicate.

  • K082276Synthemed DeviceSynthemed, Inc. · 2008
  • K070496Advacoat Sinus Gel and StentCarbylan Biosurgery · 2007
  • K052099Nasopore Nasal Dressing, Model Ndox-Yyy/ZZPolyganics B.V., · 2005
  • K043035Sepragel Ent Bioresorbable Packing/StentGenzyme Corporation · 2005
  • K033666HemadermMedafor, Inc. · 2003

More from Carbylan Biosurgery

2 FDA decisions under this applicant name. See the company

  • K070496Advacoat Sinus Gel and StentCarbylan Biosurgery · 2007

Recent decisions in LYA

The LYA category page

  • K243655TurbAlignSpirair, Inc. · 2025
  • K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc. · 2023
  • K213153SPIWay Endonasal Access GuideSpiway, LLC · 2021
  • K202623Novapak Nasal Sinus Packing and StentMedtronic Xomed · 2020
  • K181696ChitoZolveGyrus Acmi, Inc. · 2018

https://510kreport.com/device/K063308 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063308: Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063308

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026