FDA product code HRP: Pen, Marking, Surgical
HRP is the FDA product code for pen, marking, surgical. It is a Class I device, regulated under 21 CFR 886.4570 and reviewed by the Ophthalmic panel. Devices under HRP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Pen, Marking, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 886.4570 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for HRP devices
openFDA lists no recalls for product code HRP.
Frequently asked questions
What is FDA product code HRP?
HRP is the FDA product code for pen, marking, surgical. It is a Class I device, regulated under 21 CFR 886.4570 and reviewed by the Ophthalmic panel.
What device class is HRP?
Class I, regulation 21 CFR 886.4570. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HRP
- Run a recall and safety report across every HRP manufacturer
- Watch product code HRP 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.