510(k) K260817
K260817 is an FDA 510(k) premarket notification submitted by Virtual Incision for the device "MIRA Surgical System". The FDA issued a decision of Substantially Equivalent on Aug 20, 2026. The device falls under product code SAB (Table Mounted Miniaturized Electromechanical Surgical System), a Class II device regulated under 21 CFR 878.4962. Virtual Incision has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 20, 2026
- Date Received
- Mar 13, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table Mounted Miniaturized Electromechanical Surgical System
- Device Class
- Class II
- Regulation Number
- 878.4962
- Review Panel
- SU
- Submission Type
A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical devices miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms