510(k) Report

FDA applicant

Gynetics Medical Products NV

Irvine, CA4 decisions2001–20040 recalls

FDA records 4 decisions for Gynetics Medical Products NV (Irvine, CA) from 2001 to 2004: 4 510(k) clearances. Most are in product codes MQF (Catheter, Assisted Reproduction) and MQE (Needle, Assisted Reproduction). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Gynetics Medical Products NV’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gynetics Medical Products NV since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gynetics Medical Products NV 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?

  • MQFCatheter, Assisted Reproduction2decisions
  • MQENeedle, Assisted Reproduction1decision
  • HFFAspirator, Endometrial1decision

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.

  • K013536Emtrac; Delphin; Semtrac 2000 SetGynetics Medical Products NV · 20011cites it
  • K013501Iui, Model 4220; Smooze, Model 4225, L; Seminor, Model 4502 a, BGynetics Medical Products NV · 20011cites it

What has FDA decided for it lately?

  • K041237EchosamplerGynetics Medical Products NV · 2004
  • K013536Emtrac; Delphin; Semtrac 2000 SetGynetics Medical Products NV · 2001
  • K013501Iui, Model 4220; Smooze, Model 4225, L; Seminor, Model 4502 a, BGynetics Medical Products NV · 2001
  • K013497Fas Set #4551Gynetics Medical Products NV · 2001

All 4 as Gynetics Medical Products NV →