510(k) Report

FDA applicant

Rz Medizintechnik GmbH

Mühlheim An Der Donau, DE3 decisions2008–20250 recalls

FDA records 3 decisions for Rz Medizintechnik GmbH (Mühlheim An Der Donau, DE) from 2008 to 2025: 3 510(k) clearances. Most are in product codes HRX (Arthroscope) and HIH (Hysteroscope (And Accessories)). Its devices cite 3 predicates, 0 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, orthopedic panel, where it files most

How often FDA has decided Rz Medizintechnik GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2008: 12014: 12025: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Rz Medizintechnik GmbH by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HRXArthroscope1decision
  • HIHHysteroscope (And Accessories)1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K130778Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH · 20142cite it

What has FDA decided for it lately?

  • K243382RZ Resectoscope SystemRz Medizintechnik GmbH · 2025
  • K130778Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH · 2014
  • K082902RZ Endoscopic (Minimally Invasive) Instruments and AccessoriesRz Medizintechnik GmbH · 2008

All 3 as Rz Medizintechnik GmbH →