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

    RPI DUAL PORT IRRIGATION ADAPTER

    K Number: K964920 · Decision Jul 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    3
    Review Days
    212

    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
    RPI DUAL PORT IRRIGATION ADAPTER
    K Number
    K964920
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ridge Products, Inc.
    Date Received
    December 9, 1996
    Decision Date
    July 9, 1997
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

    Similar 510(k) Clearances

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

    XNY Disposable Gastric Calibration Tube

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

    Flexi-Seal AIR (with ENFit Connector)

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

    hygh-tec Drainage II

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

    ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

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

    Entarik NI Feeding Tube System

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

    CORGRIP* SR NG/NI Tube Retention System

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

    Other Clearances by Ridge Products, Inc.

    K Number Device Name
    K902641 RPI ENTERAL FEEDING BAG 1000ML AND 500ML
    K902729 R.P.I. GRAVITY SAFE FEEDING BAG