FDA product code OXT: Percutaneous Surgical Set With Attachments
OXT is the FDA product code for percutaneous surgical set with attachments. It is a Class II device, regulated under 21 CFR 878.4805 and reviewed by the General and Plastic Surgery panel. Devices under OXT reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Minimally invasive devices with the means to penetrate soft tissue to access the abdomen. The attachment and the shaft will be assembled and disassembled within the abdomen before and after use. The devices are used to grasp, hold, and manipulate soft tissues.
Classification
| Field | Value |
|---|---|
| Device name | Percutaneous Surgical Set With Attachments |
| Device class | Class II |
| Regulation | 21 CFR 878.4805 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for OXT devices
openFDA lists no recalls for product code OXT.
Frequently asked questions
What is FDA product code OXT?
OXT is the FDA product code for percutaneous surgical set with attachments. It is a Class II device, regulated under 21 CFR 878.4805 and reviewed by the General and Plastic Surgery panel.
What device class is OXT?
Class II, regulation 21 CFR 878.4805. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OXT
- Run a recall and safety report across every OXT manufacturer
- Watch product code OXT 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times