Anovo Surgical System (6Ne)
FDA 510(k) clearance K260804 · decided 2026-07-22
Clearance details
- K-number
- K260804
- Device name
- Anovo Surgical System (6Ne)
- Applicant
- Momentis Surgical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-03-12
- Decision date
- 2026-07-22
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- SCV
- Device class
- 2
- Regulation number
- 878.4964
- 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 |
|---|---|---|
| Versius Surgical System (Versius Plus) (K252111) | Cmr Surgical Limited | 2025-12-16 |
| Hugo™ RAS System (K250725) | Covidien, LLC | 2025-12-03 |
| Versius Surgical System (DEN230078) | Cmr Surgical Limited | 2024-10-11 |
Recalls involving this device
No recalls on record reference this clearance.