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

    REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER

    K Number: K133578 · Decision Apr 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    36
    Applicant Total
    32
    Review Days
    140

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    Basic Information

    Device Name
    REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
    K Number
    K133578
    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
    Stryker Sustainability Solutions
    Date Received
    November 21, 2013
    Decision Date
    April 10, 2014
    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

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    Other Clearances by Stryker Sustainability Solutions

    K Number Device Name
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    K241758 Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
    K241606 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
    K233471 Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)
    K231621 Reprocessed ViewFlex Xtra ICE Catheter (D087031)
    K230255 Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019
    K230251 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
    K222019 Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)
    K220481 Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
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