MRH
- Product code
- MRH
- Device name
- Pump, Infusion, Ophthalmic
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.5725
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 20
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K253760 | 2026-08-04 | Sight Sciences, Inc. | OMNI Ultra Surgical System (1-110) summary |
| K243503 | 2025-02-14 | New World Medical, Inc. | VIA360 Surgical System summary |
Official FDA classification page: MRH
Classification and pathway per current FDA publications. Data from openFDA (CC0).