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

    SURGICAL INSTRUMENT PROTECTOR

    K Number: K771123 · Decision Oct 28, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    47
    Review Days
    128

    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
    SURGICAL INSTRUMENT PROTECTOR
    K Number
    K771123
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Devon Industries, Inc.
    Date Received
    June 22, 1977
    Decision Date
    October 28, 1977
    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 Devon Industries, Inc.

    K Number Device Name
    K961993 BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)
    K954015 ABG POINT LOK NEEDLE PROTECTION DEVICE
    K946289 DEVONS POINT LOK NEEDLE PROTECTION DEVICE
    K945197 THE SHARPS COLLECTION AND DISPOSAL SYSTEM
    K943892 POINT OF USE SHARPS A GATOR
    K944114 PHLEBOTOMY UNIT SHARPS A GATOR
    K945485 ABG NEEDLE PROTECTION
    K932998 EASY-ON
    K912824 DEVON SPONGE COUNTER BAGS
    K894170 DEVON DISPOSABLE HEAD POSITIONER COVER
    Search all 47 clearances from Devon Industries, Inc. →