FDA product code SHC: Low Electric Field Generator For Pancreatic Cancer Treatment
SHC is the FDA product code for low electric field generator for pancreatic cancer treatment. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under SHC reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Intended to treat pancreatic cancer through delivery of low electric fields in patients receiving concomitant systemic therapies or other standard of care treatment(s)
Classification
| Field | Value |
|---|---|
| Device name | Low Electric Field Generator For Pancreatic Cancer Treatment |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for SHC devices
openFDA lists no recalls for product code SHC.
Frequently asked questions
What is FDA product code SHC?
SHC is the FDA product code for low electric field generator for pancreatic cancer treatment. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is SHC?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SHC
- Run a recall and safety report across every SHC manufacturer
- Watch product code SHC 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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