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

    FOLEY-TEMP(TM)

    K Number: K882130 · Decision Aug 9, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    27
    Applicant Total
    7
    Review Days
    81

    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
    FOLEY-TEMP(TM)
    K Number
    K882130
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mallinckroot, Inc.
    Date Received
    May 20, 1988
    Decision Date
    August 9, 1988
    Product Code
    EYB
    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
    EYB Catheter, Ureteral, Gastro-Urology

    Similar 510(k) Clearances

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

    RocaTub Ureteral Catheter

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

    Dornier MINNOW Ureteral Catheter

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

    UPJ Occlusion Balloon Catheter

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

    Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter

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

    Ureteric Catheters

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

    Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter

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

    Other Clearances by Mallinckroot, Inc.

    K Number Device Name
    K983830 COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER
    K894445 MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE
    K885348 A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL
    K885216 ATTACHABLE LANZ (TENTATIVE)
    K884159 SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT
    K884481 CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE