SAQClass II
Electromechanical System For Open Microsurgery
21 CFR 878.4963 / General, Plastic Surgery
SAQ is the FDA product code for Electromechanical System For Open Microsurgery, a class II device type, regulated under 21 CFR 878.4963. FDA's definition for this code reads: "An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SAQ
- Device name
- Electromechanical System For Open Microsurgery
- FDA definition
- An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached to an electromechanical arm.
- Regulation
- 21 CFR 878.4963
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code SAQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
| 2025 | 4 |
Applicants with the most clearances
Product code SAQ| Applicant | Clearances |
|---|---|
| Medical Microinstruments, Inc. | 4 |
| Mmi North America, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.