Versius Surgical System— 510(k) DEN230078

Name: FDA 510(k) clearance DEN230078
Creator: U.S. Food and Drug Administration
Published: 2024-10-11

Unknown

Cmr Surgical Limited

FDA 510(k) clearance DEN230078 for Versius Surgical System, Unknown on 2024-10-11. 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: 2023-11-21
Decision date: 2024-10-11
Decision: Unknown
Clearance type: Direct
Location: Cambridge, GB

View on FDA.gov ↗

Recent devices under product code SCV

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K260804 — Anovo Surgical System (6Ne)2026-07-22
K252111 — Versius Surgical System (Versius Plus)2025-12-16
K250725 — Hugo RAS System2025-12-03

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.