HNQClass I
Hook, Ophthalmic
21 CFR 886.4350 / Ophthalmic
HNQ is the FDA product code for Hook, Ophthalmic, a class I device type, regulated under 21 CFR 886.4350. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- HNQ
- Device name
- Hook, Ophthalmic
- Regulation
- 21 CFR 886.4350
- 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
- 10
- Ingested recalls
- 4
Clearances, product code HNQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1979 | 1 |
| 1980 | 1 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 2002 | 1 |
| 2003 | 1 |
Applicants with the most clearances
Product code HNQ| Applicant | Clearances |
|---|---|
| Edward Weck, Inc. | 4 |
| Advanced Surgical Products, Inc. | 1 |
| Eye-Ko, Inc. | 1 |
| Keeler Instruments, Inc. | 1 |
| Look, Inc. | 1 |
| Ophtec USA, Inc. | 1 |
| Stephens Instruments, Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
