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510(k) Data Aggregation

    K Number
    K200902
    Device Name
    ClickClean
    Date Cleared
    2020-04-30

    (27 days)

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

    Medeon Biodesign, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
    Device Description
    The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
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    K Number
    K193652
    Device Name
    AbClose - Port Site Closure Device
    Date Cleared
    2020-03-26

    (87 days)

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

    Medeon Biodesign, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
    Device Description
    The AbClose™ - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques. The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by folding the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.
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    K Number
    K150382
    Device Name
    Radio Therapy Treatment Chair
    Date Cleared
    2015-09-16

    (210 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIATION PRODUCTS DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This versatile Treatment Chair provides upright positioning for specialty treatment cases of head, neck, thorax, breast and lung or for patients who have difficulty lying supine for treatments. The seated patient has improved comfort increased lung volume and reduced respiratory motion. The treatment chair will be used on Medical Linear Accelerator treatment couch located in a hospital or clinic. A physician and physicist will prescribe its use for a treatment on a patient.
    Device Description
    Not Found
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    K Number
    K091548
    Device Name
    AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A
    Date Cleared
    2009-08-07

    (72 days)

    Product Code
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 5L318 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical / HeartStream ForeRunner AED; specifically Philips Medical battery part number BT1. This battery has a shelf life of 4 years from the date of manufacture. The AM5070 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical / HeartStream FRx and HeartStart Home AED; specifically Philips Medical battery part number AM5070A. This battery has a shelf life of 4 years from the date of manufacture.
    Device Description
    Non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment. These devices provide a means of supplying electrical power through chemical reaction. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current used by the device into which they are installed. The performance and life span of these batteries depends on operating conditions of temperature, current drain, and the discharge method. These parameters are taken into account in designing such batteries. The goal is to develop battery packs that maintain capacity for as high and as long as possible under a specified range of environmental conditions.
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    K Number
    K082861
    Device Name
    AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561
    Date Cleared
    2008-11-25

    (57 days)

    Product Code
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 2L561 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED; specifically Cardiac Science Model / Part Number 9141-001. This battery has a shelf life of 4 years from the date of manufacture. The 7L877 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED G3; specifically Cardiac Science Model / Part Number 9146-001. This battery has a shelf life of 4 years from the date of manufacture.
    Device Description
    Non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment. These devices provide a means of supplying electrical power through chemical reaction. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current used by the device into which they are installed. The performance and life span of these batteries depends on operating conditions of temperature, current drain, and the discharge method. These parameters are taken into account in designing such batteries. The goal is to develop battery packs that maintain capacity for as high and as long as possible under a specified range of environmental conditions.
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    K Number
    K073716
    Device Name
    LIFE+CEL OR LIFECEL BATTERY
    Date Cleared
    2008-04-11

    (102 days)

    Product Code
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 6L785 Sealed Manganese Dioxide (MnO2) life+cel (or lifecel) is a replacement disposable battery pack, for use in the Philips Medical Systems FR2 Series AED, specifically OEM Part Number M3863A. This battery pack has a shelf life of 5 years from the date of manufacture.
    Device Description
    Non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment. The Amco 6L785 battery chemistry is Manganese Dioxide (MnO2) based and is non rechargeable.
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    K Number
    K072596
    Device Name
    LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500
    Date Cleared
    2008-01-24

    (132 days)

    Product Code
    Regulation Number
    870.5310
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 5L500 Lithium life+cel or lifecel is a replacement battery pack for the Medtronic LifePak 500 AED. Since non-rechargeable batteries and battery packs are "device specific", and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, charge, or install these devices. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals, EMT's, etc. therefore know that the intended use is as a replacement battery. The replacement battery pack in this submission, Amco Part Number 5L500, is to be provided by prescription only.
    Device Description
    The AMCO 5L500 life+cel™ Non-rechargeable battery pack is utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment.
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    K Number
    K071164
    Device Name
    LIFE+CEL BATTERY
    Date Cleared
    2007-12-07

    (225 days)

    Product Code
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To power the functions of various devices for which batteries or battery packs are configured. Since rechargeable batteries and battery packs are "device specific", and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, charge, or install these devices. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals, EMT's, etc. therefore know that the intended use is as a replacement battery. Only replacement battery 2L226 in this submission (Patient Monitor) is provided Over-the-Counter (OTC). All other replacement batteries, specifically; 5L375, 6L577, 7L991, 9L977, 9L990, and 9L998 in this submission (Defib/AED's) are provided by prescription only.
    Device Description
    Amco rechargeable and non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d -c power source for portable as well as stationary medical equipment.
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    K Number
    K043533
    Device Name
    SURGICAL DESIGN CIRCUMCISION CLAMP
    Date Cleared
    2005-04-01

    (100 days)

    Product Code
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A circumcision clamp is used in a circumcision procedure to compress the foreskin of the penis during circumcision of a male infant or child.
    Device Description
    The Surgical Design Gomco Circumcision Clamp is a disposable medical device that is constructed of Chrome Plated Brass. The device will be sold Non Sterile for further processing(i.e. Packaging and Sterilization) by the Final Distributors. We do not intend to sell these devices to the end users.
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    K Number
    K041405
    Device Name
    ASPIRATION PUMP, MODEL IMD-020
    Date Cleared
    2004-09-02

    (99 days)

    Product Code
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    INDUSTRIAL & MEDICAL DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aspiration Pump is indicated for vacuum extractions, aspiration and removal of surgical fluids, bodily fluids, or infection materials during surgical procedures.
    Device Description
    The Aspirating Pump consists of battery powered microprocessor controlled diaphragm pump, pressure release valve, and disposable collection chamber with bacterial filter and overflow protection. Suction tubing from a patient connected to collection chamber by means of lure connector.
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