FDA product code OEE: Diagnostic Low Electric Field
OEE is the FDA product code for diagnostic low electric field. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under OEE reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation.
Classification
| Field | Value |
|---|---|
| Device name | Diagnostic Low Electric Field |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OEE devices
openFDA lists no recalls for product code OEE.
Frequently asked questions
What is FDA product code OEE?
OEE is the FDA product code for diagnostic low electric field. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is OEE?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OEE
- Run a recall and safety report across every OEE manufacturer
- Watch product code OEE 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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