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

    SHELLY PROTECTED AV FISTULA NEEDLE

    K Number: K992653 · Decision Oct 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    78
    Applicant Total
    10
    Review Days
    82

    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
    SHELLY PROTECTED AV FISTULA NEEDLE
    K Number
    K992653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diasol, Inc.
    Date Received
    August 6, 1999
    Decision Date
    October 27, 1999
    Product Code
    FIE
    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
    FIE Needle, Fistula

    Similar 510(k) Clearances

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

    JMS CAVEO A.V. Fistula Needle Set

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

    DORA Disposable A.V. Fistula Needle Sets

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

    Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)

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

    DORA Disposable A.V. Fistula Needle Sets

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

    JMS Harmony A.V. Fistula Needle Set

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

    ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET

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

    Other Clearances by Diasol, Inc.

    K Number Device Name
    K130511 CITRISOL ACID CONCENTRATE
    K020231 DIASOL-ADDITIVES
    K020230 DIASOL-BICARB
    K011004 NEEDLELOK HYPODERMIC NEEDLE PROTECTION
    K010958 FISTULOK FISTULA NEEDLE PROTECTION
    K011003 SAFESTING AND SAFESTING HUB
    K993187 SHELLY PROTECTED AV FISTULA NEEDLE
    K992999 DAISY PROTECTED SCALP VEIN SET
    K993212 DRYASOL ACID CONCENTRATE MIX