510(k) DEN190022
DEN190022 is an FDA 510(k) premarket notification submitted by Momentis Surgical , Ltd. for the device "Hominis Surgical System". The FDA issued a decision of De Novo Granted on February 26, 2021. The device falls under product code QNM (Mountable Electromechanical Surgical System For Transluminal Approaches), a Class II device regulated under 21 CFR 878.4961. Momentis Surgical , Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 26, 2021
- Date Received
- April 17, 2019
- Clearance Type
- Direct
- 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.