HOZClass II
Sponge, Ophthalmic
21 CFR 886.4790 / Ophthalmic
HOZ is the FDA product code for Sponge, Ophthalmic, a class II device type, regulated under 21 CFR 886.4790. As of , FDA records hold 47 510(k) clearances under this code, the most recent dated , and 10 recalls.
Classification record
- Product code
- HOZ
- Device name
- Sponge, Ophthalmic
- Regulation
- 21 CFR 886.4790
- Device class
- Class II
- 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
- 47
- Ingested recalls
- 10
Clearances, product code HOZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1978 | 2 |
| 1980 | 1 |
| 1983 | 1 |
| 1984 | 3 |
| 1985 | 7 |
| 1987 | 1 |
| 1989 | 3 |
| 1990 | 4 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 2 |
| 1997 | 4 |
| 1998 | 1 |
| 1999 | 4 |
| 2000 | 1 |
| 2001 | 3 |
| 2008 | 1 |
| 2009 | 1 |
| 2013 | 2 |
Applicants with the most clearances
Product code HOZ| Applicant | Clearances |
|---|---|
| Visitec Co. | 5 |
| Ultracell Medical Technologies, Inc. | 4 |
| JEDMED Instrument Company | 3 |
| Alcon Laboratories | 1 |
| Alphamed, Inc. | 1 |
| Ascon Medical Instruments, Ltd. | 1 |
| Associated Medical Products Co. | 1 |
| Biological & Environmental Control Laboratories | 1 |
| DeRoyal Industries, Inc. | 1 |
| HuiZhou Foryou Medical Devices Co., Ltd. | 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.