FDA product code HOG: Burr, Corneal, Battery-Powered
HOG is the FDA product code for burr, corneal, battery-powered. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under HOG, from 5 different applicants. The average 510(k) review took 103 days (median 97).
Classification
| Field | Value |
|---|---|
| Device name | Burr, Corneal, Battery-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.4070 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HOG clearance
Top HOG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| S. Percy Amoils | 1 | 1997-01-09 |
| Alcon Laboratories, Inc. | 1 | 1996-03-11 |
| Aaron Medical Industries | 1 | 1995-05-02 |
| Gy-Ro Industry, Inc. | 1 | 1989-01-05 |
| Jedmed Instrument Co. | 1 | 1984-03-19 |
Most recent HOG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K962989 | S. Percy Amoils | AMOILS EPITHELIAL SCRUBBER | 1997-01-09 | 161 |
| K960261 | Alcon Laboratories, Inc. | PALLIKARIS BRUSH | 1996-03-11 | 53 |
| K950520 | Aaron Medical Industries | BURR, CORNEAL, BATTERY-POWERED | 1995-05-02 | 85 |
| K883785 | Gy-Ro Industry, Inc. | GY-RO SAFE | 1989-01-05 | 120 |
| K834354 | Jedmed Instrument Co. | OPHTEC RUST RING REMOVER | 1984-03-19 | 97 |
Recalls for HOG devices
openFDA lists no recalls for product code HOG.
Frequently asked questions
What is FDA product code HOG?
HOG is the FDA product code for burr, corneal, battery-powered. It is a Class I device, regulated under 21 CFR 886.4070 and reviewed by the Ophthalmic panel.
What device class is HOG?
Class I, regulation 21 CFR 886.4070. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOG?
Across 5 cleared submissions the average was 103 days from receipt to decision (median 97).
Which companies have the most HOG clearances?
S. Percy Amoils (1); Alcon Laboratories, Inc. (1); Aaron Medical Industries (1); Gy-Ro Industry, Inc. (1); Jedmed Instrument Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HOG
- Run a recall and safety report across every HOG manufacturer
- Watch product code HOG 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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