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

    Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)

    K Number: K232511 · Decision Apr 29, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    36
    Applicant Total
    23
    Review Days
    255

    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
    Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
    K Number
    K232511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Service and Savings, Inc.
    Date Received
    August 18, 2023
    Decision Date
    April 29, 2024
    Product Code
    NUJ
    Advisory Committee
    General, Plastic Surgery
    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
    NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

    Similar 510(k) Clearances

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

    Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Green OR Reprocessed Aquamantys Bipolar Sealer

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Reprocessed LigaSure Maryland Jaw Sealer/Divider

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Surgical Instrument Service and Savings, Inc.

    K Number Device Name
    K250314 Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
    K252405 Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter
    K250772 Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
    K250545 Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
    K243101 Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)
    K242225 Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
    K241156 Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401
    K234064 Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)
    K240972 Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
    K221067 Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
    Search all 23 clearances from Surgical Instrument Service and Savings, Inc. →