FDA product code MKN: Catheter, Balloon, Transcervical
MKN is the FDA product code for catheter, balloon, transcervical. It is a Class III device, reviewed by the Obstetrics and Gynecology panel. Devices under MKN reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Balloon, Transcervical |
| Device class | Class III |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MKN devices
openFDA lists no recalls for product code MKN.
Frequently asked questions
What is FDA product code MKN?
MKN is the FDA product code for catheter, balloon, transcervical. It is a Class III device, reviewed by the Obstetrics and Gynecology panel.
What device class is MKN?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MKN
- Run a recall and safety report across every MKN manufacturer
- Watch product code MKN 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.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times