510(k) Report

FDA applicant

Cmr Surgical Limited

Cambridge, GB3 decisions2024–20261 recall

FDA records 3 decisions for Cmr Surgical Limited (Cambridge, GB) from 2024 to 2026: 2 510(k) clearances and 1 De Novo grant. All are in product code SCV (Modular Electromechanical Surgical System). Its devices cite 1 predicate, 1 of them its own earlier devices. 1 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 Cmr Surgical Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024: 12025: 12026 (partial year): 1
2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2024high 1 (2026) · low 0 (2024)2026

Class I Class II/III not classified

FIG. 1 — Cmr Surgical Limited by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • SCVModular Electromechanical Surgical System3decisions

Who builds on its devices?

Later devices cite its devices 3 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.

  • DEN230078Versius Surgical SystemCmr Surgical Limited · 20243cite it

What has FDA decided for it lately?

  • K261252Versius Surgical System (Versius Plus)Cmr Surgical Limited · 2026
  • K252111Versius Surgical System (Versius Plus)Cmr Surgical Limited · 20251 recall
  • DEN230078Versius Surgical SystemCmr Surgical Limited · 2024

All 3 as Cmr Surgical Limited →

What has been recalled?

1 recall linked to its devices; the latest:

  • K252111Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US…Jun 9, 2026Class II