FDA product code MEQ: System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
MEQ is the FDA product code for system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under MEQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 6 PMA applications cite this product code. FDA has posted 9 recalls for MEQ devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MEQ devices
9 product recalls in 8 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-04-28.
Frequently asked questions
What is FDA product code MEQ?
MEQ is the FDA product code for system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is MEQ?
Class III. Typical premarket route: PMA.
Have MEQ devices been recalled?
Yes: 9 product recalls across 8 recall events; the most recent began 2011-04-28.
Next steps
- Run an FDA pathway report with predicate devices for product code MEQ
- Run a recall and safety report across every MEQ manufacturer
- Watch product code MEQ 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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