Viscous Fluid System
FDA 510(k) K963434 · Escalon Trek Medical
510(k) numberK963434
Submission
- Device name
- Viscous Fluid System
- Applicant
- Escalon Trek Medical
Mukwonago, WI, US - Received
- August 30, 1996
- Decision date
- November 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MRH – Pump, Infusion, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K253760 | OMNI Ultra Surgical System (1-110)MRH · Traditional | Sight Sciences, Inc. | 08/04/2026SE |
| K243503 | VIA360 Surgical SystemMRH · Traditional | New World Medical, Inc. | 02/14/2025SE |
| K232214 | OMNI Surgical SystemMRH · Special | Sight Sciences, Inc. | 08/25/2023SE |
| K213173 | TrabEx ProMRH · Traditional | Microsurgical Technologies, Inc. | 06/08/2022SE |
| K212797 | iPrime Viscodelivery SystemMRH · Traditional | Glaukos | 01/06/2022SE |
| K211680 | Streamline Surgical SystemMRH · Traditional | New World Medical, Inc. | 10/08/2021SE |
| K202678 | OMNI Surgical SystemMRH · Traditional | Sight Sciences, Inc. | 03/01/2021SE |
| K201953 | OMNI PLUS Surgical SystemMRH · Special | Sight Sciences, Inc. | 08/11/2020SE |
| K173332 | OMNI Surgical SystemMRH · Traditional | Sight Sciences, Inc. | 12/21/2017SE |
| K171905 | VISCO 360 Viscosurgical SystemMRH · Special | Sight Sciences, Inc. | 07/27/2017SE |
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Questions and answers
When was Viscous Fluid System cleared by the FDA?
Viscous Fluid System (K963434) received a 510(k) decision of Substantially Equivalent on November 25, 1996, 87 days after the submission was received.
What is the product code of K963434?
The FDA product code is MRH – Pump, Infusion, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.