FDA product code HOZ: Sponge, Ophthalmic
HOZ is the FDA product code for sponge, ophthalmic. It is a Class II device, regulated under 21 CFR 886.4790 and reviewed by the Ophthalmic panel. FDA has cleared 47 510(k) submissions under HOZ, from 38 different applicants. The average 510(k) review took 100 days (median 73). FDA has posted 10 recalls for HOZ devices, 6 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Sponge, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 886.4790 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HOZ clearance
Top HOZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Visitec Co. | 5 | 1993-12-27 |
| Ultracell Medical Technologies, Inc. | 4 | 2001-08-24 |
| Jedmed Instrument Co. | 3 | 1991-04-10 |
| Huizhou Foryou Medical Devices Co., Ltd. | 1 | 2013-10-30 |
| Network Medical Products, Ltd. | 1 | 2013-10-29 |
33 more applicants have HOZ clearances. See the full list in Caduvo.
Most recent HOZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K132796 | Huizhou Foryou Medical Devices Co., Ltd. | SUNTOUCH EYE SPEAR | 2013-10-30 | 54 |
| K130117 | Network Medical Products, Ltd. | NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS | 2013-10-29 | 286 |
| K091240 | Alphamed, Inc. | ALPHAMED SURGICAL SPEAR, MODEL 70-5000 | 2009-10-23 | 179 |
| K082460 | Longtek Scientific Co., Ltd. | CENEFOM PVA SURGICAL SPEAR | 2008-12-15 | 111 |
| K012196 | Ultracell Medical Technologies, Inc. | ULTRACELL ABSORBENT STICK | 2001-08-24 | 42 |
Recalls for HOZ devices
10 product recalls in 6 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2024-10-22.
| Year | Recalls |
|---|---|
| 2022 | 3 |
| 2024 | 3 |
Frequently asked questions
What is FDA product code HOZ?
HOZ is the FDA product code for sponge, ophthalmic. It is a Class II device, regulated under 21 CFR 886.4790 and reviewed by the Ophthalmic panel.
What device class is HOZ?
Class II, regulation 21 CFR 886.4790. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HOZ?
Across 47 cleared submissions the average was 100 days from receipt to decision (median 73).
Which companies have the most HOZ clearances?
Visitec Co. (5); Ultracell Medical Technologies, Inc. (4); Jedmed Instrument Co. (3); Huizhou Foryou Medical Devices Co., Ltd. (1); Network Medical Products, Ltd. (1).
Have HOZ devices been recalled?
Yes: 10 product recalls across 6 recall events; the most recent began 2024-10-22.
Next steps
- Run an FDA pathway report with predicate devices for product code HOZ
- Run a recall and safety report across every HOZ manufacturer
- Watch product code HOZ 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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