510(k) K242368
- Device
- Symani Surgical System
- Applicant
- Medical Microinstruments, Inc.
- 510(k) number
- K242368
- Product code
- SAQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-07
- Date received
- 2024-08-09
- Regulation
- 878.4963
- Classification name
- Electromechanical System For Open Microsurgery
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Zainab Amini
- Address
- Via Egidio Giannessi 54 Pisa IT 56121 56121
FDA Registration Numbers#
- 3033523743
- 3030831003
- 3030954512
Source Documents#
Other 510(k) Records For Product Code SAQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252287 | Symani Surgical System | Medical Microinstruments, Inc. | 2025-11-10 |
| K251510 | Symani Surgical System | Medical Microinstruments, Inc. | 2025-09-04 |
| K250014 | Symani Surgical System (820-03830) | Medical Microinstruments, Inc. | 2025-01-27 |
| DEN230032 | Symani Surgical System | Mmi North America, Inc. | 2024-04-05 |