FDA product code KYH: Endoscope, Ophthalmic
KYH is the FDA product code for endoscope, ophthalmic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under KYH. The average 510(k) review took 49 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Endoscope, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KYH clearance
Top KYH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gm Engineering, Inc. | 1 | 1994-05-24 |
Most recent KYH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K941660 | Gm Engineering, Inc. | GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT | 1994-05-24 | 49 |
Recalls for KYH devices
openFDA lists no recalls for product code KYH.
Frequently asked questions
What is FDA product code KYH?
KYH is the FDA product code for endoscope, ophthalmic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Ophthalmic panel.
What device class is KYH?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code KYH?
Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most KYH clearances?
Gm Engineering, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KYH
- Run a recall and safety report across every KYH manufacturer
- Watch product code KYH 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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