HRGClass I
Engine, Trephine, Accessories, Ac-Powered
21 CFR 886.4070 / Ophthalmic
HRG is the FDA product code for Engine, Trephine, Accessories, Ac-Powered, a class I device type, regulated under 21 CFR 886.4070. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- HRG
- Device name
- Engine, Trephine, Accessories, Ac-Powered
- Regulation
- 21 CFR 886.4070
- Device class
- Class I
- Review panel
- Ophthalmic
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 6
- Ingested recalls
- 0
Clearances, product code HRG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1998 | 1 |
| 2001 | 1 |
Applicants with the most clearances
Product code HRG| Applicant | Clearances |
|---|---|
| Bkg Opthalmics USA, Inc. | 1 |
| Edward Weck, Inc. | 1 |
| Intl. Ophthalmic Industries Corp. | 1 |
| Laser Center Dev. Corp. | 1 |
| Optical Systems Intl., Inc. | 1 |
| Scanlan Intl., Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code HRG.
FIRST ARTICLE / WEEKLY
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