Electromechanical System For Open Microsurgery
An electromechanical system for open microsurgery is a software-controlled electromechanical platform with bedside human/device interfaces and no integrated visualization system, enabling a qualified surgeon to perform open microsurgical techniques using instruments attached to electromechanical arms. It is classified as FDA Class II (510(k) required) under regulation 878.4963 in the General and Plastic Surgery specialty, with product code SAQ. The device is not an implant and does not support life-sustaining functions.
Basic Information
- Product Code
- SAQ
- Device Class
- FDA class 2
- Regulation Number
- 878.4963
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached to an electromechanical arm.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242368 | Symani Surgical System | Feb 07, 2025 | Substantially Equivalent | Medical Microinstruments, Inc. |
| K250014 | Symani Surgical System (820-03830) | Jan 27, 2025 | Substantially Equivalent | MEDICAL MICROINSTRUMENTS, INC. |
| DEN230032 | Symani Surgical System | Apr 05, 2024 | Unknown | MMI North America, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.