510(k) Report

FDA applicant

Carbylan Biosurgery

Palo Alto, CA2 decisions2006–20070 recalls

FDA records 2 decisions for Carbylan Biosurgery (Palo Alto, CA) from 2006 to 2007: 2 510(k) clearances. All are in product code LYA (Splint, Intranasal Septal). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Carbylan Biosurgery’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Carbylan Biosurgery by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LYASplint, Intranasal Septal2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070496Advacoat Sinus Gel and StentCarbylan Biosurgery · 20072cite it
  • K063308Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200Carbylan Biosurgery · 20061cites it

What has FDA decided for it lately?

  • K070496Advacoat Sinus Gel and StentCarbylan Biosurgery · 2007
  • K063308Advacoat Sinus Gel, Model 9100, Adva Sinus Stent, Model 9200Carbylan Biosurgery · 2006

All 2 as Carbylan Biosurgery →