FDA product code MIK: Device, Ultrasonic, Thermal Ablation
MIK is the FDA product code for device, ultrasonic, thermal ablation. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under MIK reach the market by PMA; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Device, Ultrasonic, Thermal Ablation |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MIK devices
openFDA lists no recalls for product code MIK.
Frequently asked questions
What is FDA product code MIK?
MIK is the FDA product code for device, ultrasonic, thermal ablation. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is MIK?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MIK
- Run a recall and safety report across every MIK manufacturer
- Watch product code MIK 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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