BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ENDOMETRIAL SAMPLER

    K Number: K901896 · Decision Aug 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    102
    Applicant Total
    18
    Review Days
    110

    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
    ENDOMETRIAL SAMPLER
    K Number
    K901896
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.5410
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Kirwan Surgical Products, Inc.
    Date Received
    April 25, 1990
    Decision Date
    August 13, 1990
    Product Code
    EJF
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EJF Bracket, Metal, Orthodontic

    Similar 510(k) Clearances

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

    BITEM LOCK, MODELS SW006, SW012

    FDA 510(k)
    FDA Class 1 ·Dental

    MICROARCH GOLD BRACKET

    FDA 510(k)
    FDA Class 1 ·Dental

    ALASTIK

    FDA 510(k)
    FDA Class 1 ·Dental

    MEMORY WIRE

    FDA 510(k)
    FDA Class 1 ·Dental

    ORTHOTECH DURA-GOLD BARCKETS

    FDA 510(k)
    FDA Class 1 ·Dental

    FASCINATION CERAMIC BRACKET

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Kirwan Surgical Products, Inc.

    K Number Device Name
    K100912 DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
    K070360 KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601
    K060915 KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
    K062659 KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES
    K052203 AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600
    K023482 AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500
    K992218 DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601
    K982176 KIRWAN SURGICAL PRODUCTS, INC. MODEL 28 1500 ELECTROSURGERY GENERATOR
    K971341 KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR
    K965241 BIPOLAR SUCTION COAGULATOR
    Search all 18 clearances from Kirwan Surgical Products, Inc. →