FDA product code OHW: Burr, Corneal, Battery Powered, Rust Ring Removal
OHW is the FDA product code for burr, corneal, battery powered, rust ring removal. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel. Devices under OHW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OHW devices.
Definition
A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye and is class I exempt when intended only for rust ring removal.
Classification
| Field | Value |
|---|---|
| Device name | Burr, Corneal, Battery Powered, Rust Ring Removal |
| Device class | Class I |
| Regulation | 21 CFR 886.4070 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Recalls for OHW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-10-12.
Frequently asked questions
What is FDA product code OHW?
OHW is the FDA product code for burr, corneal, battery powered, rust ring removal. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel.
What device class is OHW?
Class I, regulation 21 CFR 886.4070. Typical premarket route: 510(k) exempt.
Have OHW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-10-12.
Next steps
- Run an FDA pathway report with predicate devices for product code OHW
- Run a recall and safety report across every OHW manufacturer
- Watch product code OHW 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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