LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K052457
    Device Name
    PICSI SPERM SELECTION DEVICE
    Manufacturer
    BIOCOAT, INC.
    Date Cleared
    2006-04-13

    (218 days)

    Product Code
    MQK, MQL
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCOAT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In the treatment of infertile couples by ICSI, PICSI is indicated for the selection of mature sperm for injection.
    Device Description
    The PICSI™ Sperm Selection Device is a sterile, plastic culture dish with three microdots of hyaluronan hydrogel attached to the dish and three locating lines emoussed on the bottom exterior of the dish to aid the operator to find the microdots. Mature sperm attach themselves to hyaluronan through specific receptors on the sperm plasma membrane. At temperatures from 18-28° C, mature sperm attach firmly to the hyaluronan microdot and no longer exhibit progressive movement, although their tails beat and they are capable of motility. Such sperm are removed from the hyaluronan by micropipet for intracytoplasmic sperm injection (ICSI).
    Ask a Question
    K Number
    K032874
    Device Name
    HBA SPERM-HYALURONAN BINDING ASSAY
    Manufacturer
    BIOCOAT, INC.
    Date Cleared
    2003-11-24

    (70 days)

    Product Code
    POV, GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOCOAT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. As a component of the standard analysis of semen in the diagnosis of suspected male infertility, - 2. As a component of analyses for determining the proper course of IVF treatment of infertility.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 1