SCV — Modular Electromechanical Surgical System Class II
FDA product code SCV covers "Modular Electromechanical Surgical System", a Class II medical device regulated under 21 CFR 878.4964. Submissions are reviewed by the General, Plastic Surgery panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SCV
- Device Class
- Class II
- Regulation Number
- 878.4964
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures.