FDA Product Code
FDA Product Code MRH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253760 | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | 2026-08-04 | Traditional | PDF ↗ |
| K243503 | VIA360 Surgical System | New World Medical, Inc. | 2025-02-14 | Traditional | PDF ↗ |
| K232214 | OMNI Surgical System | Sight Sciences, Inc. | 2023-08-25 | Special | PDF ↗ |
| K213173 | TrabEx Pro | Microsurgical Technologies, Inc. | 2022-06-08 | Traditional | PDF ↗ |
| K212797 | iPrime Viscodelivery System | Glaukos | 2022-01-06 | Traditional | PDF ↗ |
| K211680 | Streamline Surgical System | New World Medical, Inc. | 2021-10-08 | Traditional | PDF ↗ |
| K202678 | OMNI Surgical System | Sight Sciences, Inc. | 2021-03-01 | Traditional | PDF ↗ |
| K201953 | OMNI PLUS Surgical System | Sight Sciences, Inc. | 2020-08-11 | Special | PDF ↗ |
| K173332 | OMNI Surgical System | Sight Sciences, Inc. | 2017-12-21 | Traditional | PDF ↗ |
| K171905 | VISCO 360 Viscosurgical System | Sight Sciences, Inc. | 2017-07-27 | Special | PDF ↗ |
| K143205 | Viscoelastic Injector | Sight Sciences, Inc. | 2014-12-05 | Special | PDF ↗ |
| K132494 | VISCOELASTIC INJECTOR | Sight Sciences, Inc. | 2013-10-22 | Traditional | PDF ↗ |
| K050716 | ISCIENCE SURGICAL VISCOINJECTOR | Iscience Surgical Corporation | 2005-04-21 | Traditional | PDF ↗ |
| K000420 | SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003 | Retinalabs.Com | 2000-05-08 | Traditional | PDF ↗ |
| K993039 | VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700) | Bausch & Lomb, Inc. | 2000-01-07 | Traditional | PDF ↗ |
| K981907 | V.F.I.-VISCOUS FLUID INFUSION TUBING SET | Peregrine Surgical , Ltd. | 1998-08-04 | Traditional | PDF ↗ |
| K974253 | CPD COMMANDER | Scieran Technologies, Inc. | 1998-02-25 | Traditional | PDF ↗ |
| K972664 | STORZ MILLENNIUM VISCOUS FLUID SYSTEM | Storz Instrument Co. | 1997-10-10 | Traditional | PDF ↗ |
| K971067 | DIGI-INJECTOR | Medical Instrument Development Laboratories, Inc. | 1997-09-19 | Traditional | PDF ↗ |
| K963434 | VISCOUS FLUID SYSTEM | Escalon Trek Medical | 1996-11-25 | Traditional | PDF ↗ |
Product code MRH · Class II · General Hospital. Data: openFDA.