Symani Surgical System (820-03830)
FDA 510(k) clearance K250014 · decided 2025-01-27
Clearance details
- K-number
- K250014
- Device name
- Symani Surgical System (820-03830)
- Applicant
- Medical Microinstruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-02
- Decision date
- 2025-01-27
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- SAQ
- Device class
- 2
- Regulation number
- 878.4963
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Pisa, IT
- 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 |
|---|---|---|
| Symani Surgical System (K252287) | Medical Microinstruments, Inc. | 2025-11-10 |
| Symani Surgical System (K251510) | Medical Microinstruments, Inc. | 2025-09-04 |
| Symani Surgical System (K242368) | Medical Microinstruments, Inc. | 2025-02-07 |
| Symani Surgical System (DEN230032) | Mmi North America, Inc. | 2024-04-05 |
Recalls involving this device
No recalls on record reference this clearance.