FDA product code HMN: Suture, Nonabsorable, Ophthalmic
HMN is the FDA product code for suture, nonabsorable, ophthalmic. It is a Class III device, reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under HMN. The average 510(k) review took 16 days (median 16).
Classification
| Field | Value |
|---|---|
| Device name | Suture, Nonabsorable, Ophthalmic |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Compare with all 510(k) review times · Search every HMN clearance
Top HMN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Myocure, Inc. | 1 | 1982-08-25 |
Most recent HMN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822392 | Myocure, Inc. | MYOCUR BLADE PAC | 1982-08-25 | 16 |
Recalls for HMN devices
openFDA lists no recalls for product code HMN.
Frequently asked questions
What is FDA product code HMN?
HMN is the FDA product code for suture, nonabsorable, ophthalmic. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is HMN?
Class III. Typical premarket route: PMA.
How long does a 510(k) take for product code HMN?
Across 1 cleared submissions the average was 16 days from receipt to decision (median 16).
Which companies have the most HMN clearances?
Myocure, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HMN
- Run a recall and safety report across every HMN manufacturer
- Watch product code HMN 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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