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

    FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM

    K Number: K071127 · Decision Nov 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    33
    Review Days
    207

    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
    FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM
    K Number
    K071127
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vision-Sciences, Inc.
    Date Received
    April 23, 2007
    Decision Date
    November 16, 2007
    Product Code
    HIH
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIH Hysteroscope (And Accessories)

    Similar 510(k) Clearances

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

    Strauss Surgical Resection Instruments

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Manual Tissue Removal Device

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    InnovexView (GC146-17, GC150-20, GC155-23)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SPY Cystoscope/Hysteroscope

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    RZ Resectoscope System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Vision-Sciences, Inc.

    K Number Device Name
    K102733 VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
    K100125 VISION SCIENCES FLEXIBLE ENT SCOPE
    K091768 VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
    K072180 VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
    K072088 FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS
    K072073 VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR
    K071903 ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
    K053560 MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
    K050972 VISION-SCIENCES ENT-3000 SCOPE
    K040984 VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
    Search all 33 clearances from Vision-Sciences, Inc. →