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

    SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE

    K Number: K936071 · Decision Aug 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    22
    Review Days
    242

    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
    SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE
    K Number
    K936071
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Smith & Nephew Dyonics, Inc.
    Date Received
    December 20, 1993
    Decision Date
    August 19, 1994
    Product Code
    HET
    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
    HET Laparoscope, Gynecologic (And Accessories)

    Similar 510(k) Clearances

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

    SIRIUS Endoscope System (PR-SI-1230)

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

    i-Cut

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

    SIRIUS Endoscope System

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

    Video Endoscopy System, 3D Video Endoscopy System

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

    Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5

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

    SurroundScope System

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

    Other Clearances by Smith & Nephew Dyonics, Inc.

    K Number Device Name
    K955914 LIMITED REUSE ARTHROSCOPIC BLADES
    K954627 ECTRA II LIGAMENT RELEASE SYSTEM
    K954989 DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
    K953695 DYONICS DISPOSABLE ARTHROSCOPIC BLADES
    K953387 ECTRA LIGAMENT RELEASE SYSTEM
    K945182 DYONICS FIXATION SCREWS
    K934299 DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION
    K920267 DYONICS ARTHROSCOPIC KIT
    K922176 INTELIJET SUCTION SUPPLY
    K914963 SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET
    Search all 22 clearances from Smith & Nephew Dyonics, Inc. →