meddevicedb.com FDA Device Reference

Versius Surgical System

DEN230078 Class II Direct
Decision Date
2024-10-11
Sponsor / Applicant
Cmr Surgical Limited

Technical Specification

510(k) Submission ID DEN230078
Product Code SCV
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4964
Decision Date 2024-10-11
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Versius Surgical System received FDA 510(k) clearance under submission number DEN230078, sponsored by Cmr Surgical Limited. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-10-11.

Classification & Regulation

This clearance is catalogued under FDA product code SCV and 21 CFR 878.4964, within the General, Plastic Surgery review panel as a Class II device.