510(k) DEN230078
- Device
- Versius Surgical System
- Applicant
- Cmr Surgical Limited
- 510(k) number
- DEN230078
- Product code
- SCV
- Decision
- Unknown (DENG)
- Decision date
- 2024-10-11
- Date received
- 2023-11-21
- Regulation
- 878.4964
- Classification name
- Modular Electromechanical Surgical System
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Chris Weatherall
- Address
- 1 Evolution Business Park Milton Rd. Cambridge GB CB24 9NG CB24 9NG
FDA Registration Numbers#
- 9611102
- 3010193531
- 3010372554
- 3008889904
- 3010408671
- 9612501
- 2248148
- 3018094310
- 1219930
- 3004105270
- 3017636737
- 3007029079
- 3008132398
- 9614969
- 3015488559
Source Documents#
510(k) summary PDF not indicated by FDA