Versius Surgical System (Versius Plus)— 510(k) K261252

Name: FDA 510(k) clearance K261252
Creator: U.S. Food and Drug Administration
Published: 2026-10-21

Substantially Equivalent

Cmr Surgical Limited

FDA 510(k) clearance K261252 for Versius Surgical System (Versius Plus), Substantially Equivalent on 2026-10-21. Applicant: Cmr Surgical Limited. Device class: 2.

Clearance details

Applicant: Cmr Surgical Limited
Product code: Product code SCV
Device class: Class 2
Regulation: 21 CFR 878.4964
Advisory panel: General, Plastic Surgery
Date received: 2026-04-16
Decision date: 2026-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code SCV

view all

K260804 — Anovo Surgical System (6Ne)2026-07-22
K252111 — Versius Surgical System (Versius Plus)2025-12-16
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 →

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