510(k) DEN230032
DEN230032 is an FDA 510(k) premarket notification submitted by Mmi North America, Inc. for the device "Symani Surgical System". The FDA issued a decision of De Novo Granted on Apr 5, 2024. The device falls under product code SAQ (Electromechanical System For Open Microsurgery), a Class II device regulated under 21 CFR 878.4963.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Apr 5, 2024
- Date Received
- Apr 25, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electromechanical System For Open Microsurgery
- Device Class
- Class II
- Regulation Number
- 878.4963
- Review Panel
- SU
- Submission Type
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.