Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K182274
    Device Name
    Orbit Subretinal Delivery System
    Manufacturer
    Orbit Biomedical, Inc.
    Date Cleared
    2018-11-20

    (90 days)

    Product Code
    FMF, HMX
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orbit Biomedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.
    Device Description
    The Orbit Subretinal Delivery System is designed for microinjection into the subretinal space. The Orbit Subretinal Delivery System is comprised of 2 kits: the Subretinal Access Kit and the Third Arm Kit. All Subretinal Access Kit components are supplied sterile and intended for single-use only and cannot be reused or resterilized. The Subretinal Access Kit contains the following device components: Subretinal Injection Cannula, Ophthalmic Marker, Syringes, and Tubing Set. The assembled Third Arm Kit functions as a "third arm" to stabilize the subretinal injection cannula and free the surgeon's hands during the procedure. The Third Arm Kit (supplied nonsterile) is reusable and must be cleaned and sterilized prior to each use. Together, the Subretinal Access Kit and the Third Arm Kit are to deliver the infusate (e.g., BSS. BSS® PLUS) to the subretinal space as described in the Instructions for Use.
    Ask a Question

    Page 1 of 1