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

    Medline ReNewal Reprocessed Endopath Endoscopic Instruments

    K Number: K152313 · Decision Jan 6, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    36
    Applicant Total
    4
    Review Days
    142

    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 Endopath Endoscopic Instruments
    K Number
    K152313
    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 Services and Savings, Inc.
    Date Received
    August 17, 2015
    Decision Date
    January 6, 2016
    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.

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

    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

    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
    View all

    Other Clearances by Surgical Instrument Services and Savings, Inc.

    K Number Device Name
    K232130 Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
    K162751 Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
    K150524 Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology