FDA product code HRT: Stripper, Surgical
HRT is the FDA product code for stripper, surgical. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel. Devices under HRT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Stripper, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 888.4540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) exempt |
Recalls for HRT devices
openFDA lists no recalls for product code HRT.
Frequently asked questions
What is FDA product code HRT?
HRT is the FDA product code for stripper, surgical. It is a Class I device, regulated under 21 CFR 888.4540 and reviewed by the Orthopedic panel.
What device class is HRT?
Class I, regulation 21 CFR 888.4540. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HRT
- Run a recall and safety report across every HRT manufacturer
- Watch product code HRT 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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