510(k) Report

FDA applicant

Spirox, Inc.

Menlo Park, CA3 decisions2014–20160 recalls

FDA records 3 decisions for Spirox, Inc. (Menlo Park, CA) from 2014 to 2016: 3 510(k) clearances. All are in product code NHB (Polymer, Ear, Nose And Throat, Synthetic…). Its devices cite 6 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 Spirox, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014: 12015: 12016: 1
2014high 1 (2014) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Spirox, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable3decisions

Whose devices does it build on?

Its devices cite 6 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.

  • K152958INEX Absorbable Nasal ImplantSpirox, Inc. · 20151cites it
  • K132920Spirox Inex DeviceSpirox, Inc. · 20141cites it
  • K161191Latera Absorbable Nasal ImplantSpirox, Inc. · 20161cites it

What has FDA decided for it lately?

  • K161191Latera Absorbable Nasal ImplantSpirox, Inc. · 2016
  • K152958INEX Absorbable Nasal ImplantSpirox, Inc. · 2015
  • K132920Spirox Inex DeviceSpirox, Inc. · 2014

All 3 as Spirox, Inc. →