510(k) Report

FDA applicant

Gyrx, LLC

Jacksonville, FL2 decisions2003–20040 recalls

FDA records 2 decisions for Gyrx, LLC (Jacksonville, FL) from 2003 to 2004: 2 510(k) clearances. Most are in product codes FZP (Clip, Implantable) and NJC (Clip, Vas Deferens). 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, general and plastic surgery panel, where it files most

How often FDA has decided Gyrx, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gyrx, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Gyrx, LLC 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?

  • FZPClip, Implantable1decision
  • NJCClip, Vas Deferens1decision

What has FDA decided for it lately?

  • K034029TI Clip ApplierGyrx, LLC · 2004
  • K033161Visu-Lock 5MM Clip ApplierGyrx, LLC · 2003

All 2 as Gyrx, LLC →