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510(k) Data Aggregation

    K Number
    K232130
    Device Name
    Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter
    Manufacturer
    Surgical Instrument Services and Savings, Inc
    Date Cleared
    2023-12-15

    (151 days)

    Product Code
    OWQ
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Instrument Services and Savings, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures; blood flow and other devices within the heart.
    Device Description
    The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The reprocessed ViewFlex Xtra is a sterile, single use, temporary, intracardiac catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles. Each device is marked and tracked and taken out of service once the maximum number of cycles has been reached.
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    K Number
    K162751
    Device Name
    Medline ReNewal Reprocessed Ligasure Curved, Small Jaw Open Sealer/Divider
    Manufacturer
    Surgical Instrument Services and Savings, Inc
    Date Cleared
    2017-05-01

    (213 days)

    Product Code
    NUJ
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Instrument Services and Savings, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medline ReNewal Reprocessed LigaSure Curved Small Jaw, Open Sealer/Divide LF1212A is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgical specialties as urologic, thoracic, plastic and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures. Nissen fundoplication, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectory, and tonsillectorny) for ligation and division of vessels, lymphatiss and tissue bundles 2 - 3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands. The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
    Device Description
    The Medline ReNewal Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open general surgical procedures. Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue. The surgeon first grasps the vessel or tissue with the jaws of the instrument. Once the surgeon is confident that the instrument is placed correctly, he or she initiates a seal by pressing a hand switch or footswitch. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Once the seal cycle is complete, the surgeon actuates a blade within the instrument to divide tissue along the seal line. The 10-foot cord, cable connector, and generator are not reprocessed by Medline ReNewal.
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    K Number
    K152313
    Device Name
    Medline ReNewal Reprocessed Endopath Endoscopic Instruments
    Manufacturer
    Surgical Instrument Services and Savings, Inc
    Date Cleared
    2016-01-06

    (142 days)

    Product Code
    NUJ
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Instrument Services and Savings, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mm Diameter Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection of tissue.
    Device Description
    Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mm Diameter Endoscopic Instruments (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected packaged, labeled, and sterilize for an additional clinical use.
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    K Number
    K150524
    Device Name
    Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
    Manufacturer
    Surgical Instrument Services and Savings, Inc
    Date Cleared
    2015-12-16

    (289 days)

    Product Code
    NLQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Instrument Services and Savings, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology is indicated for soft-tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to, or substitute for, electrosurgery, lasers, and steel scalpels in general, otorhinolaryngolic (ear, nose and throat [ENT]), plastic, pediatic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.
    Device Description
    Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected, packaged, and sterilized for an additional clinical use.
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