BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    I/A BAC STOP KIT

    K Number: K850899 · Decision Mar 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    22
    Review Days
    25

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    I/A BAC STOP KIT
    K Number
    K850899
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Staar Surgical Co.
    Date Received
    March 4, 1985
    Decision Date
    March 29, 1985
    Product Code
    HQC
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQC Unit, Phacofragmentation

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HQC), ordered by most recent decision date.

    Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    System Sophi

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MICOR 700 with Auto I/A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Staar Surgical Co.

    K Number Device Name
    K090161 EPIPHANY INJECTION SYSTEM
    K073591 MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
    K073586 MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
    K032412 RE-USEABLE MICROSTAAR INJECTOR, MSI-S
    K020734 SURGE-FREE ASPIRATION ADAPTER
    K983129 DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
    K980696 FOAM TIP INJECTOR
    K954600 MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
    K913626 SOFTRANS INJECTOR
    K884241 STAAR PHACO XL SMALL INCISION SYSTEM
    Search all 22 clearances from Staar Surgical Co. →