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

    SURGITEK ALL SILICONE INFECTION DOUBJ

    K Number: K833782 · Decision Apr 2, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    29
    Review Days
    157

    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
    SURGITEK ALL SILICONE INFECTION DOUBJ
    K Number
    K833782
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Surgitek
    Date Received
    October 28, 1983
    Decision Date
    April 2, 1984
    Product Code
    FAD
    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
    FAD Stent, Ureteral

    Similar 510(k) Clearances

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

    Disposable Ureteral Stents

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

    Endura™ Ureteral Stent and Stent Set

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

    Ureteral Stents (AF-D series)

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

    Disposable ureteral stent

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

    Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set

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

    RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm

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

    Other Clearances by Surgitek

    K Number Device Name
    K946296 QUADRA-COIL URETERAL STENT
    K944391 OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM
    K943491 RIGHT ANGLE UROLOGIC LASER FIBER
    K941952 SURGITEK INFUSER
    K933261 GRASPING FORCEPS
    K933260 HELICAL STONE/FLATWIRE STONE BASKETS
    K930733 URETERAL STENT
    K930483 URETERAL CATHETER
    K926344 HYDROPHILIC COATED GUIDEWIRE
    K920451 ENDOTEK ULTRA SYSTEM
    Search all 29 clearances from Surgitek →