510(k) K260804
- Device
- Anovo Surgical System (6Ne)
- Applicant
- Momentis Surgical , Ltd.
- 510(k) number
- K260804
- Product code
- SCV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-22
- Date received
- 2026-03-12
- Regulation
- 878.4964
- Classification name
- Modular Electromechanical Surgical System
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Maya Leib Shlomo
- Address
- 6 Yoni Netanyahu St. Or Yehuda IL 6037604 6037604
FDA Registration Numbers#
- 3008889904
- 3004105270
- 3008132398
- 3010372554
- 3017636737
- 9611102
- 3015488559
- 1219930
- 9614969
- 3010408671
- 3010193531
- 2248148
- 9612501
- 3007029079
- 3018094310