FDA product code HNQ: Hook, Ophthalmic
HNQ is the FDA product code for hook, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 10 510(k) submissions under HNQ, from 7 different applicants. The average 510(k) review took 41 days (median 26). FDA has posted 4 recalls for HNQ devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Hook, 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 HNQ clearance
Top HNQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Edward Weck, Inc. | 4 | 1980-07-28 |
| Ophtec, USA | 1 | 2003-04-17 |
| Stephens Instruments | 1 | 2002-11-01 |
| Advanced Surgical Products, Inc. | 1 | 1988-04-13 |
| Look, Inc. | 1 | 1987-02-20 |
2 more applicants have HNQ clearances. See the full list in Caduvo.
Most recent HNQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030471 | Ophtec, USA | OPHTEC ENCLAVATION NEEDLE | 2003-04-17 | 64 |
| K022842 | Stephens Instruments | STEPHENS DISPOSABLE HOOKS | 2002-11-01 | 66 |
| K874991 | Advanced Surgical Products, Inc. | PRISMA DISPOSABLE IRRIGATING IRIS HOOK | 1988-04-13 | 133 |
| K870440 | Look, Inc. | LOOK LENS LOOPS | 1987-02-20 | 17 |
| K864292 | Eye-Ko, Inc. | DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY | 1986-12-29 | 59 |
Recalls for HNQ devices
4 product recalls in 3 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-12-16.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code HNQ?
HNQ is the FDA product code for hook, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNQ?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNQ?
Across 10 cleared submissions the average was 41 days from receipt to decision (median 26).
Which companies have the most HNQ clearances?
Edward Weck, Inc. (4); Ophtec, USA (1); Stephens Instruments (1); Advanced Surgical Products, Inc. (1); Look, Inc. (1).
Have HNQ devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2025-12-16.
Next steps
- Run an FDA pathway report with predicate devices for product code HNQ
- Run a recall and safety report across every HNQ manufacturer
- Watch product code HNQ 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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