510(k) K242368
K242368 is an FDA 510(k) premarket notification submitted by Medical Microinstruments, Inc. for the device "Symani Surgical System". The FDA issued a decision of Substantially Equivalent on Feb 7, 2025. The device falls under product code SAQ (Electromechanical System For Open Microsurgery), a Class II device regulated under 21 CFR 878.4963. Medical Microinstruments, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 7, 2025
- Date Received
- Aug 9, 2024
- Clearance Type
- Traditional
- 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.