Anovo Pedestal
FDA 510(k) clearance K232146 · decided 2023-09-14
Clearance details
- K-number
- K232146
- Device name
- Anovo Pedestal
- Applicant
- Momentis Surgical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-19
- Decision date
- 2023-09-14
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- QNM
- Device class
- 2
- Regulation number
- 878.4961
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Or Yehuda, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (K251761) | Momentis Surgical , Ltd. | 2025-07-08 |
| Anovo Surgical System (6Ne) (K250591) | Momentis Surgical , Ltd. | 2025-06-06 |
| Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (K251056) | Momentis Surgical , Ltd. | 2025-05-02 |
| Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode (K243182) | Momentis Surgical , Ltd. | 2025-02-03 |
| Anovo Surgical System (Model 6Ne) (K242157) | Momentis Surgical , Ltd. | 2024-10-21 |
| Anovo Surgical System (model 6N) (K241907) | Momentis Surgical , Ltd. | 2024-10-02 |
| Hominis Surgical System (DEN190022) | Momentis Surgical , Ltd. | 2021-02-26 |
Recalls involving this device
No recalls on record reference this clearance.