FDA product code HNJ: Punch, Corneo-Scleral
HNJ is the FDA product code for punch, corneo-scleral. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HNJ, from 3 different applicants. The average 510(k) review took 30 days (median 35). FDA has posted 1 recall for HNJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Punch, Corneo-Scleral |
| 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 HNJ clearance
Top HNJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ocular Instruments, Inc. | 1 | 1987-05-18 |
| Jedmed Instrument Co. | 1 | 1983-03-09 |
| Edward Weck, Inc. | 1 | 1979-10-30 |
Most recent HNJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871646 | Ocular Instruments, Inc. | TANNE CORNEAL CUTTING BLOCK | 1987-05-18 | 20 |
| K830335 | Jedmed Instrument Co. | DORC CORNEAL PUNCH BLOCK | 1983-03-09 | 36 |
| K791988 | Edward Weck, Inc. | REPL. PISTON FOR TROUTMAN CORNEAL PUNCH | 1979-10-30 | 35 |
Recalls for HNJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-06-27.
Frequently asked questions
What is FDA product code HNJ?
HNJ is the FDA product code for punch, corneo-scleral. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HNJ?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HNJ?
Across 3 cleared submissions the average was 30 days from receipt to decision (median 35).
Which companies have the most HNJ clearances?
Ocular Instruments, Inc. (1); Jedmed Instrument Co. (1); Edward Weck, Inc. (1).
Have HNJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-06-27.
Next steps
- Run an FDA pathway report with predicate devices for product code HNJ
- Run a recall and safety report across every HNJ manufacturer
- Watch product code HNJ 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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