510(k) Report

FDA applicant

Sinusys Corporation

Orinda, CA2 decisions2013–20160 recalls

FDA records 2 decisions for Sinusys Corporation (Orinda, CA) from 2013 to 2016: 2 510(k) clearances. All are in product code LRC (Instrument, Ent Manual Surgical). Its devices cite 4 predicates, 0 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 Sinusys Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2013: 12016: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Sinusys Corporation by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LRCInstrument, Ent Manual Surgical2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K160770Vent-Os Sinus Dilation familySinusys Corporation · 2016
  • K133016Vent-OS Sinus Dilation SystemSinusys Corporation · 2013

All 2 as Sinusys Corporation →