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

    CK10000 SERIES POUCH & BAGS ETC.

    K Number: K834558 · Decision Sep 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    13
    Review Days
    252

    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
    CK10000 SERIES POUCH & BAGS ETC.
    K Number
    K834558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Currie Medical Specialties, Inc.
    Date Received
    December 28, 1983
    Decision Date
    September 5, 1984
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

    Similar 510(k) Clearances

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

    SteriBest® Sterilization Tray System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SteriTite Container System with MediTray Products

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Straumann® ProClean™ Cassette (041.800 ; 041.801)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Stainless Steel Surgical Kits

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterilization Trays

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Currie Medical Specialties, Inc.

    K Number Device Name
    K151158 ALP VasQcare Take Home System
    K143317 Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)
    K140092 CURRIE MEDICAL REPROCESSED ALP CALF/THIGH/FOOT COMPRESSION SLEEVE (ALL SIZES)
    K112311 ALP 501 RB PUMP SYSTEM
    K902441 DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS)
    K874760 CK 4900 SERIES, GOWN AND TOWEL PAK
    K872395 CK 1600 SERIES, TOWELS
    K871737 CK 7000 SERIES 5 IN 1 CONNECTOR AND Y-CONNECTOR
    K864816 CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE
    K864697 CK 6000 SERIES, TOWELS
    Search all 13 clearances from Currie Medical Specialties, Inc. →