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

    FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B

    K Number: K061210 · Decision Jun 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    9
    Review Days
    57

    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
    FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B
    K Number
    K061210
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kyphon, Inc.
    Date Received
    May 1, 2006
    Decision Date
    June 27, 2006
    Product Code
    BSP
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

    Similar 510(k) Clearances

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

    SonoMSK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SonoPlex STIM; SonoPlex II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SonoTAP and SonoTAP II

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SonoBlock; SonoBlock II

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

    Other Clearances by Kyphon, Inc.

    K Number Device Name
    K073516 DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR
    K063071 DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B
    K041454 KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
    K041584 KYPHX HV-R BONE CEMENT, MODEL C01A
    K033801 KYPHX HV-R, MODEL C01A
    K032212 KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
    K010246 KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A
    K981251 KYPHON INFLATABLE BONE TAMP