510(k) K232146
- Device
- Anovo Pedestal
- Applicant
- Momentis Surgical , Ltd.
- 510(k) number
- K232146
- Product code
- QNM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-14
- Date received
- 2023-07-19
- Regulation
- 878.4961
- Classification name
- Mountable Electromechanical Surgical System For Transluminal Approaches
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Maya Leib Shlomo
- Address
- 3 Yahadut Canada St. Or Yehuda IL 6037503 6037503
FDA Registration Numbers#
- 3008729892
- 3014155960
- 3003623887
Source Documents#
Other 510(k) Records For Product Code QNM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251761 | Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | Momentis Surgical , Ltd. | 2025-07-08 |
| K250591 | Anovo Surgical System (6Ne) | Momentis Surgical , Ltd. | 2025-06-06 |
| K251056 | Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode | Momentis Surgical , Ltd. | 2025-05-02 |
| K243182 | Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode | Momentis Surgical , Ltd. | 2025-02-03 |
| K242157 | Anovo Surgical System (Model 6Ne) | Momentis Surgical , Ltd. | 2024-10-21 |
| K241907 | Anovo Surgical System (model 6N) | Momentis Surgical , Ltd. | 2024-10-02 |
| DEN190022 | Hominis Surgical System | Momentis Surgical , Ltd. | 2021-02-26 |