510(k) Report

FDA applicant

Geny Medical, Inc.

Aliso Viejo, CA2 decisions1979–20000 recalls

FDA records 2 decisions for Geny Medical, Inc. (Aliso Viejo, CA) from 1979 to 2000: 2 510(k) clearances. Most are in product codes FBK (Endoscopic Injection Needle…) and JEC (Component, Traction, Invasive). 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Geny Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Geny Medical, 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?

  • FBKEndoscopic Injection Needle, Gastroenterology-Urology1decision
  • JECComponent, Traction, Invasive1decision

Who builds on its devices?

Later devices cite its devices 4 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.

  • K792561Mini-H-FixationGeny Medical, Inc. · 19793cite it
  • K001146Genyx Flexible Injection NeeedleGeny Medical, Inc. · 20001cites it

What has FDA decided for it lately?

  • K001146Genyx Flexible Injection NeeedleGeny Medical, Inc. · 2000
  • K792561Mini-H-FixationGeny Medical, Inc. · 1979

All 2 as Geny Medical, Inc. →