FDA product code MGI: Aspirator, Ultrasonic
MGI is the FDA product code for aspirator, ultrasonic. It is a Class III device, reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under MGI. The average 510(k) review took 213 days (median 213).
Classification
| Field | Value |
|---|---|
| Device name | Aspirator, Ultrasonic |
| Device class | Class III |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Compare with all 510(k) review times · Search every MGI clearance
Top MGI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sharplan Lasers, Inc. | 1 | 1992-03-27 |
Most recent MGI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K913848 | Sharplan Lasers, Inc. | SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR | 1992-03-27 | 213 |
Recalls for MGI devices
openFDA lists no recalls for product code MGI.
Frequently asked questions
What is FDA product code MGI?
MGI is the FDA product code for aspirator, ultrasonic. It is a Class III device, reviewed by the Obstetrics and Gynecology panel.
What device class is MGI?
Class III. Typical premarket route: Contact FDA.
How long does a 510(k) take for product code MGI?
Across 1 cleared submissions the average was 213 days from receipt to decision (median 213).
Which companies have the most MGI clearances?
Sharplan Lasers, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MGI
- Run a recall and safety report across every MGI manufacturer
- Watch product code MGI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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