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

    ULTRASONIC HAND INSTRUMENTS

    K Number: K971861 · Decision Jul 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    218
    Review Days
    42

    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
    ULTRASONIC HAND INSTRUMENTS
    K Number
    K971861
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    May 20, 1997
    Decision Date
    July 1, 1997
    Product Code
    LFL
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LFL Instrument, Ultrasonic Surgical

    Similar 510(k) Clearances

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

    CUSA® Clarity Ultrasonic Surgical Aspirator System

    FDA 510(k)
    FDA Unclassified ·Unknown

    SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Sonopet iQ Ultrasonic Aspirator System (5500-050-000)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Tenex 2nd Generation System

    FDA 510(k)
    FDA Unclassified ·Unknown

    CUSA® Clarity Ultrasonic Surgical Aspirator System

    FDA 510(k)
    FDA Unclassified ·Unknown

    Ultrasonic Surgical System

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by United States Surgical, A Division of Tyco Healthc

    K Number Device Name
    K071406 AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
    K071920 AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
    K061288 AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
    K062850 AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
    K062326 AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
    K061095 AUTO SUTUR ENDO GIA STAPLERS
    K050947 MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
    K042412 MODIFIED SPACEMAKER SYSTEM
    K040594 HERCULON SOFT TISSUE REATTACHMENT SYSTEM
    K032696 AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
    Search all 218 clearances from United States Surgical, A Division of Tyco Healthc →