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

    IOLAB POWER I.V. POLE

    K Number: K921135 · Decision Jun 3, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    30
    Review Days
    85

    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
    IOLAB POWER I.V. POLE
    K Number
    K921135
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Site Microsurgical Systems, Inc.
    Date Received
    March 10, 1992
    Decision Date
    June 3, 1992
    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 Site Microsurgical Systems, Inc.

    K Number Device Name
    K925828 MODIFIED SITE TXR SYSTEMS
    K925921 MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE
    K931866 SITE'S CD II PHACOEMULSIFICATION HANDPIECE
    K920582 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.
    K912902 PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE
    K912739 SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
    K910980 SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
    K905620 MODIFIED SITE PERISTALTIC FOOTSWITCH
    K904183 SITE PHACOEMULSIFICATION HANDPIECE
    K904151 SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE
    Search all 30 clearances from Site Microsurgical Systems, Inc. →