510(k) Report

FDA applicant

Surgitrend, Ltd.

Englewood, CO2 decisions1990–19910 recalls

FDA records 2 decisions for Surgitrend, Ltd. (Englewood, CO) from 1990 to 1991: 2 510(k) clearances. All are in product code EMX (Balloon, Epistaxis). 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 Surgitrend, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Surgitrend, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Surgitrend, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EMXBalloon, Epistaxis2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K900171Expandacel Nasal TamponsSurgitrend, Ltd. · 19901cites it
  • K912524Expandacel Nasal Tampons, ModificationSurgitrend, Ltd. · 19911cites it

What has FDA decided for it lately?

  • K912524Expandacel Nasal Tampons, ModificationSurgitrend, Ltd. · 1991
  • K900171Expandacel Nasal TamponsSurgitrend, Ltd. · 1990

All 2 as Surgitrend, Ltd. →