BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE

    K Number: K904999 · Decision Jan 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    31
    Applicant Total
    7
    Review Days
    812

    Basic Information

    Device Name
    WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE
    K Number
    K904999
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5790
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    OPTICON MEDICAL, INC.
    Date Received
    November 6, 1990
    Decision Date
    January 26, 1993
    Product Code
    BSR
    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
    BSR Stylet, Tracheal Tube

    Similar 510(k) Clearances

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

    Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    MOLLOY INTUBATING STYLETTE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    LIGHTED FLEXGUIDE (MODIFICATION)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all

    Other Clearances by OPTICON MEDICAL, INC.

    K Number Device Name
    K033830 OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000
    K023090 OPTION-VF URINARY CATHETER, FV14218
    K970716 OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE
    K930194 HEMOSTASIS VALVE AND TUBING SET
    K895955 LOPER CELIAC PLEXUS BLOCK CATHETER KIT
    K895476 OPTION EPIDURAL CATHETERS