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

    NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO

    K Number: K925161 · Decision Jul 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    16
    Review Days
    281

    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
    NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
    K Number
    K925161
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    North American Sterilization & Packaging Co.
    Date Received
    October 13, 1992
    Decision Date
    July 21, 1993
    Product Code
    KNY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNY Accessories, Catheter, G-U

    Similar 510(k) Clearances

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

    Bi-Flex Evo

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Vesair Cystoscopic Sheath

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BI-FLEX URETERAL ACCESS SHEATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    WIJAY EZ-VOID EXTERNAL CATHETER VALVE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GUARDIAN URETHRAL SHEATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GUARDIAN URETHRAL SHEATH

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by North American Sterilization & Packaging Co.

    K Number Device Name
    K964231 NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)
    K963753 NASP TRANSPARENT DRESSING
    K962352 HYDROGEL SKIN DRESSING
    K925588 NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
    K925593 NORTEC STERILE WATER FOR DEVICE IRRIGATION
    K911865 NORTEC CONNECTING TUBE SET
    K911784 NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY
    K910691 NORTEC URETERAL STENT
    K903162 FLEXIBLE ENDOSCOPIC ELECTRODES
    K903156 CONTROL-TIP CYSTOSCOPIC ELECTRODES
    Search all 16 clearances from North American Sterilization & Packaging Co. →