FDA product code HNA: Spud, Ophthalmic
HNA is the FDA product code for spud, 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 HNA, from 2 different applicants. The average 510(k) review took 91 days (median 91).
Classification
| Field | Value |
|---|---|
| Device name | Spud, 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 HNA clearance
Top HNA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Sterile Products, Inc. | 1 | 1993-08-31 |
| Solway, Inc. | 1 | 1987-12-23 |
Most recent HNA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931449 | Medical Sterile Products, Inc. | MSP OPHTHALMIC (EYE SPUD) | 1993-08-31 | 161 |
| K874963 | Solway, Inc. | MANUAL OPHTHALMIC SURGICAL INSTRUMENTS | 1987-12-23 | 21 |
Recalls for HNA devices
openFDA lists no recalls for product code HNA.
Frequently asked questions
What is FDA product code HNA?
HNA is the FDA product code for spud, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNA?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNA?
Across 2 cleared submissions the average was 91 days from receipt to decision (median 91).
Which companies have the most HNA clearances?
Medical Sterile Products, Inc. (1); Solway, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HNA
- Run a recall and safety report across every HNA manufacturer
- Watch product code HNA 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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