510(k) K260804
K260804 is an FDA 510(k) premarket notification submitted by Momentis Surgical , Ltd. for the device "Anovo Surgical System (6Ne)". The FDA issued a decision of Substantially Equivalent on Jul 22, 2026. The device falls under product code SCV (Modular Electromechanical Surgical System), a Class II device regulated under 21 CFR 878.4964. Momentis Surgical , Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 22, 2026
- Date Received
- Mar 12, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Modular Electromechanical Surgical System
- Device Class
- Class II
- Regulation Number
- 878.4964
- Review Panel
- SU
- Submission Type
A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures.