FDA product code HNM: Needle, Ophthalmic Suturing
HNM is the FDA product code for needle, ophthalmic suturing. 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 HNM, from 2 different applicants. The average 510(k) review took 162 days (median 162). FDA has posted 2 recalls for HNM devices.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Ophthalmic Suturing |
| 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 HNM clearance
Top HNM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Optical Micro Systems, Inc. | 1 | 1985-08-21 |
| Edward Weck, Inc. | 1 | 1978-03-17 |
Most recent HNM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844448 | Optical Micro Systems, Inc. | OMS/GONVERS RETINAL PERFORATOR | 1985-08-21 | 278 |
| K780154 | Edward Weck, Inc. | NEEDLEHOLDER, MICROVASULAR 5 1/2 | 1978-03-17 | 46 |
Recalls for HNM devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-11-20.
Frequently asked questions
What is FDA product code HNM?
HNM is the FDA product code for needle, ophthalmic suturing. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNM?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNM?
Across 2 cleared submissions the average was 162 days from receipt to decision (median 162).
Which companies have the most HNM clearances?
Optical Micro Systems, Inc. (1); Edward Weck, Inc. (1).
Have HNM devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2007-11-20.
Next steps
- Run an FDA pathway report with predicate devices for product code HNM
- Run a recall and safety report across every HNM manufacturer
- Watch product code HNM 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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