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

    GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE

    K Number: K954306 · Decision Dec 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    27
    Same Product Code
    29
    Applicant Total
    9
    Review Days
    98

    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
    GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE
    K Number
    K954306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4690
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gamp & Assoc.
    Date Received
    September 15, 1995
    Decision Date
    December 22, 1995
    Product Code
    HQB
    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
    HQB Photocoagulator And Accessories

    Similar 510(k) Clearances

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

    Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MAXReach Laser Probe

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Vitreq disposable laser probes, light fibers and Chandelier

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PEREGRINE CURVED ILLUMINATING LASER PROBE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    23GA CURVED ILLUMINATING LASER PROBE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PEREGRINE 23GA CURVED LASER PROBE

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

    Other Clearances by Gamp & Assoc.

    K Number Device Name
    K952569 GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
    K952581 GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR
    K952585 GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR
    K954308 GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE
    K954307 GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE
    K952584 GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK
    K952580 GAMP & ASSOCIATES DISPOSABLE BARE END FIBER
    K952586 GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR