FDA 510(k) clearance · back to tracker

Versius Surgical System (Versius Plus)

Cmr Surgical Limited cleared K252111 on 2025-12-16, decision: substantially equivalent

K-number

K252111

Sponsor

Cmr Surgical Limited

Device

Versius Surgical System (Versius Plus)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-12-16

Product code

SCV

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4964

Official FDA record

Open K252111on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K252111 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.