BEUDAMED
    Product Code: MRH FDA class 2 21 CFR 880.5725

    Pump, Infusion, Ophthalmic

    General Hospital

    The Ophthalmic Infusion Pump is a general hospital device used to deliver balanced salt solution or other irrigating fluids to the eye at a controlled pressure and flow rate during vitreoretinal or anterior segment ophthalmic surgery. Classified as FDA Class 2 under 21 CFR 880.5725, it requires 510(k) premarket notification. The product code is MRH, reviewed by the Ophthalmic panel.

    View on FDA
    510(k)s
    19
    FEI Numbers
    18
    Registration Numbers
    18
    Unique Applicants
    12
    Years Active
    28

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    Basic Information

    Product Code
    MRH
    Device Class
    FDA class 2
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Review Panel
    OP
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 19 510(k) clearances via K numbers.

    K Number Device Name
    K243503 VIA360™ Surgical System
    K232214 OMNI Surgical System
    K213173 TrabEx Pro
    K212797 iPrime Viscodelivery System
    K211680 Streamline Surgical System
    K202678 OMNI Surgical System
    K201953 OMNI PLUS Surgical System
    K173332 OMNI Surgical System
    K171905 VISCO 360 Viscosurgical System
    K143205 Viscoelastic Injector
    K132494 VISCOELASTIC INJECTOR
    K050716 ISCIENCE SURGICAL VISCOINJECTOR
    K000420 SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003
    K993039 VISCOUS FLUID INJECTOR SYSTEM MODULE (CX5700)
    K981907 V.F.I.-VISCOUS FLUID INFUSION TUBING SET
    K974253 CPD COMMANDER
    K972664 STORZ MILLENNIUM VISCOUS FLUID SYSTEM
    K971067 DIGI-INJECTOR
    K963434 VISCOUS FLUID SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.