510(k) K251056
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2025
- Date Received
- April 4, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mountable Electromechanical Surgical System For Transluminal Approaches
- Device Class
- Class II
- Regulation Number
- 878.4961
- Review Panel
- SU
- Submission Type
A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.