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510(k) Data Aggregation

    K Number
    K201699
    Device Name
    Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
    Manufacturer
    Surgical Instrument and Savings Inc (dba Medline ReNewal)
    Date Cleared
    2020-07-22

    (30 days)

    Product Code
    NLF
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Instrument and Savings Inc (dba Medline ReNewal)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.
    Device Description
    The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR is designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor Pulse Oximeter. The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intended for prescription use with adult patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile
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    K Number
    K153258
    Device Name
    Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
    Manufacturer
    Surgical Instrument Service and Savings (dba Medline ReNewal
    Date Cleared
    2016-04-05

    (147 days)

    Product Code
    NLM
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Instrument Service and Savings (dba Medline ReNewal

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar is intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.
    Device Description
    The Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocar 5-mm, 11-mm and 12-mm, with transparent cannula and obturator, allows optical entry for visualization of tissue layers during insertion. It is available in standard (100 mm), short (70 mm) and long (150 mm) cannula lengths. The obturator housing contains a scope retention mechanism and the trocar housing contains internal seals to prevent loss of pneumoperitoneum when instruments are inserted into a port or withdrawn completely from a port. The 5-mm, 11-mm and 12-mm Versaport seal system accommodate instruments indicated as 5-mm up to 11-mm and 12-mm respectively.
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    K Number
    K151405
    Device Name
    Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology
    Manufacturer
    Surgical Instrument Services and Savings(dba Medline ReNewal
    Date Cleared
    2016-01-26

    (245 days)

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

    Surgical Instrument Services and Savings(dba Medline ReNewal

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.
    Device Description
    Medline ReNewal Reprocessed Harmonic ACE+ 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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    K Number
    K143166
    Device Name
    Medline ReNewal Reprocessed Compression Limb Sleeves
    Manufacturer
    Surgical Instrument Service and Savings (dba Medline ReNewal
    Date Cleared
    2015-01-16

    (73 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Instrument Service and Savings (dba Medline ReNewal

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medline ReNewal Reprocessed Compression Limb Sleeves are designed to be used with a pump system to apply sequential compression to the lower limbs to prevent deep vein thrombosis.
    Device Description
    Medline ReNewal Reprocessed Compression Limb Sleeves are used with a pump system to apply sequential compression to the lower limbs (leg and foot). They are made of a variety of materials and come in various sizes. They are originally manufactured as single use devices.
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    K Number
    K142022
    Device Name
    MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
    Manufacturer
    MEDLINE RENEWAL
    Date Cleared
    2014-12-19

    (147 days)

    Product Code
    NLY
    Regulation Number
    874.4140
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDLINE RENEWAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are designed for use in limited sinus applications involving soft tissue and thin bone such as lamina papyracea.
    Device Description
    Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are sterile single use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. The Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are originally manufactured by OLYMPUS/Gyrus ACMI.
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