FDA product code MIP: Implanted Fecal Incontinence Device
MIP is the FDA product code for implanted fecal incontinence device. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under MIP 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 MIP devices.
Definition
PMA Approved: P010020
Classification
| Field | Value |
|---|---|
| Device name | Implanted Fecal Incontinence Device |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MIP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-05-09.
Frequently asked questions
What is FDA product code MIP?
MIP is the FDA product code for implanted fecal incontinence device. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is MIP?
Class III. Typical premarket route: PMA.
Have MIP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-05-09.
Next steps
- Run an FDA pathway report with predicate devices for product code MIP
- Run a recall and safety report across every MIP manufacturer
- Watch product code MIP 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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