FDA product code HNZ: Curette, Ophthalmic
HNZ is the FDA product code for curette, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under HNZ, from 2 different applicants. The average 510(k) review took 39 days (median 39).
Classification
| Field | Value |
|---|---|
| Device name | Curette, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HNZ clearance
Top HNZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Look, Inc. | 1 | 1987-02-20 |
| Premier Dental Products Co. | 1 | 1984-05-09 |
Most recent HNZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870437 | Look, Inc. | LOOK CAPSULE POLISHERS/SCRAPERS | 1987-02-20 | 17 |
| K841007 | Premier Dental Products Co. | OPHTHALMIC CURETTE-VARIOUS | 1984-05-09 | 61 |
Recalls for HNZ devices
openFDA lists no recalls for product code HNZ.
Frequently asked questions
What is FDA product code HNZ?
HNZ is the FDA product code for curette, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNZ?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNZ?
Across 2 cleared submissions the average was 39 days from receipt to decision (median 39).
Which companies have the most HNZ clearances?
Look, Inc. (1); Premier Dental Products Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HNZ
- Run a recall and safety report across every HNZ manufacturer
- Watch product code HNZ 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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