Hominis Surgical System
FDA 510(k) clearance DEN190022 · decided 2021-02-26
Clearance details
- K-number
- DEN190022
- Device name
- Hominis Surgical System
- Applicant
- Momentis Surgical , Ltd.
- Decision
- Unknown
- Date received
- 2019-04-17
- Decision date
- 2021-02-26
- Days to decision
- 681 days
- Clearance type
- Direct
- 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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| 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 |
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| Anovo Surgical System (Model 6Ne) (K242157) | Momentis Surgical , Ltd. | 2024-10-21 |
| Anovo Surgical System (model 6N) (K241907) | Momentis Surgical , Ltd. | 2024-10-02 |
| Anovo Pedestal (K232146) | Momentis Surgical , Ltd. | 2023-09-14 |
Recalls involving this device
No recalls on record reference this clearance.