510(k) Report

FDA applicant

H&O Equipments, Nv/Sa

Ghislenghien, BE2 decisions2003–20160 recalls

FDA records 2 decisions for H&O Equipments, Nv/Sa (Ghislenghien, BE) from 2003 to 2016: 2 510(k) clearances. All are in product code GEH (Unit, Cryosurgical, Accessories). Its devices cite 1 predicate, 1 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, general and plastic surgery panel, where it files most

How often FDA has decided H&O Equipments, Nv/Sa’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — H&O Equipments, Nv/Sa 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?

  • GEHUnit, Cryosurgical, Accessories2decisions

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K024009CryoprobeH&O Equipments, Nv/Sa · 20035cite it

What has FDA decided for it lately?

  • K161615AccurettH&O Equipments, Nv/Sa · 2016
  • K024009CryoprobeH&O Equipments, Nv/Sa · 2003

All 2 as H&O Equipments, Nv/Sa →