FDA product code MWM: Sensor, Electro-Optical (For Cervical Cancer)
MWM is the FDA product code for sensor, electro-optical (for cervical cancer). It is a Class III device, reviewed by the Obstetrics and Gynecology panel. Devices under MWM reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for MWM devices.
Definition
An optical detection system for the identification of areas on the cervix likely to contain cancer or precancerous cells.
Classification
| Field | Value |
|---|---|
| Device name | Sensor, Electro-Optical (For Cervical Cancer) |
| Device class | Class III |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MWM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-05-15.
Frequently asked questions
What is FDA product code MWM?
MWM is the FDA product code for sensor, electro-optical (for cervical cancer). It is a Class III device, reviewed by the Obstetrics and Gynecology panel.
What device class is MWM?
Class III. Typical premarket route: PMA.
Have MWM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-05-15.
Next steps
- Run an FDA pathway report with predicate devices for product code MWM
- Run a recall and safety report across every MWM manufacturer
- Watch product code MWM 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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