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

    GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE

    K Number: K971374 · Decision May 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    9
    Review Days
    394

    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
    GREATBATCH SCIENTIFIC MR COMPATIBLE HYSTEROSCOPE
    K Number
    K971374
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wilson Greatbatch Technologies, Inc.
    Date Received
    April 14, 1997
    Decision Date
    May 13, 1998
    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 Wilson Greatbatch Technologies, Inc.

    K Number Device Name
    K971377 GREATBATCH SCIENTIFIC MR COMPATIBLE LARYNGOSCOPE
    K972280 GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
    K971781 GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
    K970619 GREATBATCH SCIENTIFIC MRI COMPATIBLE FIBER OPTIC LARYNGOSCOPE HANDLE
    K971375 GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE
    K954649 WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP
    K950063 WGL ENDOSCOPIC GRASPER*
    K942168 WGL ENDOSCOPIC GRASPER