510(k) Report

FDA applicant

Guidewire Technologies, Inc.

Salem, NH3 decisions1989–19900 recalls

FDA records 3 decisions for Guidewire Technologies, Inc. (Salem, NH) from 1989 to 1990: 3 510(k) clearances. All are in product code DQX (Wire, Guide, Catheter). 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 Guidewire Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Guidewire Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • DQXWire, Guide, Catheter3decisions

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.

  • K902153Teflon Coated GuidewireGuidewire Technologies, Inc. · 19901cites it
  • K902152Movable Core GuidewireGuidewire Technologies, Inc. · 19901cites it

What has FDA decided for it lately?

  • K902153Teflon Coated GuidewireGuidewire Technologies, Inc. · 1990
  • K902152Movable Core GuidewireGuidewire Technologies, Inc. · 1990
  • K890959GuidewireGuidewire Technologies, Inc. · 1989

All 3 as Guidewire Technologies, Inc. →