510(k) Report

FDA applicant

Accunex Canada,Inc.

Fort Worth, TX1 decision1996–19960 recalls

FDA records 1 decision for Accunex Canada,Inc. (Fort Worth, TX) in 1996: 1 510(k) clearance. All are in product code EFQ (Gauze/Sponge, Internal). Its devices cite 2 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

How often FDA has decided Accunex Canada,Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Accunex Canada,Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • EFQGauze/Sponge, Internal1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K962972Surgicade Gauze SpongeAccunex Canada,Inc. · 1996

The one decision as Accunex Canada,Inc. →