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

    STABILTUBE

    K Number: K934117 · Decision Oct 25, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    236
    Applicant Total
    3
    Review Days
    62

    Basic Information

    Device Name
    STABILTUBE
    K Number
    K934117
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    GARRETT MEDICAL PRODUCTS
    Date Received
    August 24, 1993
    Decision Date
    October 25, 1993
    Product Code
    BTR
    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
    BTR Tube, Tracheal (W/Wo Connector)

    Similar 510(k) Clearances

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

    Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LMA Fastrach ETT SU

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)

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

    Other Clearances by GARRETT MEDICAL PRODUCTS

    K Number Device Name
    K942016 TRACH TIE, VENTILATOR TUBING HOLDER
    K930179 TRACHEAL TUBE FIXATION DEVICE