510(k) Report

FDA applicant

W.L. Gore & Associates

Flagstaff, AZ3 decisions2005–20120 recalls

FDA records 3 decisions for W.L. Gore & Associates (Flagstaff, AZ) from 2005 to 2012: 3 510(k) clearances. Most are in product codes NTE (Temporary Carotid Catheter For Embolic Capture) and FTL (Mesh, Surgical, Polymeric). Its devices cite 7 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, cardiovascular panel, where it files most

How often FDA has decided W.L. Gore & Associates’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2010: 12012: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — W.L. Gore & Associates by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like W.L. Gore & Associates’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?

  • NTETemporary Carotid Catheter For Embolic Capture1decision
  • FTLMesh, Surgical, Polymeric1decision
  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K120480Gore (R) Embolic FilterW.L. Gore & Associates · 2012
  • K093934Gore Hybrid Vascular GraftW.L. Gore & Associates · 2010
  • K053202Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW.L. Gore & Associates · 2005

All 3 as W.L. Gore & Associates →