Versius Surgical System (Versius Plus)— 510(k) K252111

Name: FDA 510(k) clearance K252111
Creator: U.S. Food and Drug Administration
Published: 2025-12-16

Substantially Equivalent

Cmr Surgical Limited

FDA 510(k) clearance K252111 for Versius Surgical System (Versius Plus), Substantially Equivalent on 2025-12-16. Applicant: Cmr Surgical Limited. Device class: 2.

Clearance details

Applicant: Cmr Surgical Limited
Product code: Code SCV
Device class: Class 2
Regulation: 21 CFR 878.4964
Advisory panel: General, Plastic Surgery
Date received: 2025-07-07
Decision date: 2025-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code SCV

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K260804 — Anovo Surgical System (6Ne)2026-07-22
K250725 — Hugo RAS System2025-12-03
DEN230078 — Versius Surgical System2024-10-11

Adverse events under product code SCV

product code SCV

Malfunction: 608
Total: 608

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K252111

K-number listed on FDA's recall record

Z-2717-2026 — Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.Class II·Ongoing·CMR SURGICAL LIMITED·20260609

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K252111.

Data sourced from openFDA. This site is unofficial and independent of the FDA.