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510(k) Data Aggregation

    K Number
    K123732
    Device Name
    HYSTEROSCOPY PUMP HM6
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Date Cleared
    2013-04-04

    (120 days)

    Product Code
    HIG
    Regulation Number
    884.1700
    Why did this record match?
    Applicant Name (Manufacturer) :

    W.O.M. WORLD OF MEDICINE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hysteroscopy Pump HM6 is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.
    Device Description
    The Hysteroscopy Pump HM6 is a microprocessor controlled device that consists of the following two main components: (1) an irrigation pump unit and (2) and fluid monitoring unit that are to be placed on a cart. The irrigation pump unit is a single roller pump that functions according to the peristaltic system and includes a manmachine interface (MMI) and a touch-screen display. The Hysteroscopy Pump HM6 is to be used with specially designed single use irrigation and outflow tube sets that are supplied sterile. The fluid monitoring unit of the Hysteroscopy Pump HM6 is a microprocessor controlled device, which monitors the amount of delivered irrigation solution and compares it with the volume of the secretions returned to the container. The monitoring enables the surgeon to observe the quantity of fluids left in the patient. The irrigation pump unit of the proposed device indicates any fluid deficit that exceeds the fluid deficit level pre-set by the surgeon. The Hysteroscopy Pump HM6 determines both the inflow and outflow volume by means of two separate scales.
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    K Number
    K112642
    Device Name
    AQUILEX FLUID CONTROL SYSTEM H112
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Date Cleared
    2012-02-06

    (147 days)

    Product Code
    HIG
    Regulation Number
    884.1700
    Why did this record match?
    Applicant Name (Manufacturer) :

    W.O.M. WORLD OF MEDICINE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aquilex Fluid Control System H112 is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus.
    Device Description
    The Aquilex Fluid Control System H112 is a microprocessor controlled device that consists of the following two main components: (1) an irrigation pump unit and (2) and fluid monitoring unit that are to be placed on a special roller stand. The irrigation pump unit is a single roller pump that functions according to the peristaltic system. It is to be used with specially designed single use irrigation and outflow tube sets that are supplied sterile. The irrigation pump unit of the proposed device is only operational in conjunction with the fluid monitoring unit. Strict fluid intake and output surveillance is therefore ensured during the entire procedure.
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    K Number
    K063367
    Device Name
    45L CORE INSUFFLATOR, MODEL F114
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Date Cleared
    2007-05-23

    (197 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    W.O.M. WORLD OF MEDICINE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 45L CORE Insufflator F114 is a CO2 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application, the low flow application and the bariatric application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F114 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.
    Device Description
    The 45L CORE Insufflator F114 is a microprocessor controlled CO2 insufflator designed with a high flow application, a low flow application, a bariatric application and a vessel harvesting application. The device incorporates the following major components and features: a casing, a world power supply, pressure reducers, a venting system, a fluid sensor, a gas heater and various setting symbols and display elements. The device is equipped with a continuous pressure measurement mode and redundant discontinuos pressure measurement mode that controls the conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. In addition, a software controlled active pressure reduction ensures that the preset nominal pressure value conforms to the actual pressure that is measured in the cavity. Finally, the 45L CORE Insufflator F114 is designed with several alarms to inform the operator in case of an overpressure. The device is to be used with specially designed single-use tubing sets.
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    K Number
    K062380
    Device Name
    FLOSIMPLE ARTHROSCOPY PUMP A120
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Date Cleared
    2006-12-14

    (121 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    W.O.M. WORLD OF MEDICINE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLOSIMPLE Arthroscopy Pump A120 is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.
    Device Description
    The FLOSIMPLE Arthroscopy Pump A120 (the “A120”) is a microprocessor controlled single roller pump, which functions according to the peristaltic system. The device incorporates the following major components and features: a casing, a world power supply, a rechargeable battery pack, a touch screen display. The A120 is to be mounted on a roller-wheel stand and is to be used with a specially designed cartridge tube set and with an optional remote control. The A120 performs a continuous pressure measurement to ensure that the actual pressure in the joint cavity complies with the pre-set nominal pressure. In addition, a software controlled active pressure reduction mechanism is activated if the actual pressure measured in the joint cavity exceeds the preset nominal pressure value. The device is also designed with several alarms to inform the operator in case of an overpressure.
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    K Number
    K060723
    Device Name
    40 L HIGH FLOW INSUFFLATOR F113
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Date Cleared
    2006-05-25

    (69 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    W.O.M. WORLD OF MEDICINE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 40 L High Flow Insufflator F113 is a CO2 insufflator intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The high flow application and the low flow application of the device are each indicated for use in facilitating the use of a laparoscope by filling the peritoneal cavity with gas to distend it. The low flow application of the device is indicated for pediatric use. The vessel harvesting application of the F113 is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein and/or radial artery during endoscopic vessel harvesting procedures.
    Device Description
    The 40 L High Flow Insufflator F113 is a microprocessor controlled CO2 insufflator designed with a high flow application, a low flow application and a vessel harvesting application. The device incorporates the following major components and features: a housing, a world power supply, pressure reducers, a venting system, a fluid sensor, a gas heater and various setting keys and display elements. A continuous redundant pressure measurement controls the conformity of the actual pressure in the peritoneal or extraperitoneal cavity with the pre-set nominal pressure. In addition, a software controlled active pressure reduction ensures that the preset nominal pressure value conforms to the actual pressure that is measured in the cavity. Finally, the 40 L High Flow Insufflator F113 is designed with several alarms to inform the operator in case of an overpressure. The device may be used with a heating tube and with an optional remote control.
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    K Number
    K042457
    Device Name
    URO PRO
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Date Cleared
    2004-10-25

    (45 days)

    Product Code
    LJH
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    W.O.M. WORLD OF MEDICINE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The URO Pro is an irrigation roller pump intended for the infusion of sterile solutions into the ureter and upper urinary tract during diagnostic and/or therapeutic endoscopic urologic procedures. It is indicated for the infusion of sterile solutions through an endoscope into the urogenital tract to irrigate the ureter and upper urinary tract in a controlled manner and to improve visibility of the surgical field during urologic procedures.
    Device Description
    The URO Pro is a microprocessor controlled pump which functions according to the peristaltic principle and incorporates the following major components and features: a power supply, a main cable, a roller wheel, a pump head, various setting keys and display elements. The pump head is designed with two pressure sensors to perform redundant pressure measurement. A software controlled active sensor monitoring ensures the conformity of the preset nominal pressure value with the actual measured pressure. In addition, the URO Pro is designed with several alarms to inform the operator in case of an overpressure.
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    K Number
    K030837
    Device Name
    40 L HIGH FLOW INSUFFLATOR F108
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Date Cleared
    2004-02-05

    (325 days)

    Product Code
    HIF
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    W.O.M. WORLD OF MEDICINE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 40L High Flow Insufflator F108 with low flow mode is a device intended to facilitate the use of the laparosoope by filling the peritoneal cavity with gas to distend it. The low flow application of this device is indicated for pediatric use.
    Device Description
    The 40 L High Flow Insufflator F108 is a microprocessor controlled device designed to insufflate medical CO2 gas into peritoneal cavities during diagnostic and therapeutic laparoscopic procedures. The 40 L High Flow Insufflator F108 consists of the following main components: a housing, power supply, pressure reducers, a venting system, a fluid sensor, a gas heater, various setting kevs and display elements. A continuous redundant pressure measurement controls the conformity of the actual pressure in the abdomen with the pre-set nominal pressure. The device is to be used with a specially designed heating tube and with an optional remote control.
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    K Number
    K033927
    Device Name
    ARTHOSCOPY PUMP A115
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Date Cleared
    2004-01-15

    (28 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    W.O.M. WORLD OF MEDICINE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arthroscopy Pump A115 is intended to provide fluid distention and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.
    Device Description
    The Arthroscopy Pump A115 is a microprocessor controlled single roller pump designed to provide fluid distention and irrigation of joint cavities during diagnostic and operative arthroscopy. The pump functions according to the peristaltic principle and consists of the following main components: a housing, a power supply, a roller wheel, a pump head, various setting keys and display elements. The pump is used with special designed irrigation tubings, a pressure remove control and a foot pedal. A constant performed redundant pressure control assures conformity of the actual pressure in the joint cavity with the pre-set nominal pressure.
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    K Number
    K032023
    Device Name
    W.O.M. LASER U100PLUS
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Date Cleared
    2003-10-01

    (93 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    W.O.M. WORLD OF MEDICINE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The W.O.M. Laser U100plus is intended for use in endoscopic surgical procedures to fragment stones. The W.O.M. Laser U100plus is indicated for use to fragment urinary stones (kidney, ureter and bladder) and biliary stones in the contact mode during closed surgical procedures.
    Device Description
    The W.O.M. Laser U100plus is an intracorporal laser lithotripter in Urology and Gastroenterology. It transmits pulses of laser energy by a quartz fiber to the stone (contact mode). The laser pulses are transformed into an ultrasonic wave (acoustic impact waves) which mechanically crush the stone. The device incorporates an internal water cooling cycle with a water-air heat exchanger system. It provides safety features and displays parameters on the operator panel. Differences from the predicate W.O.M. Laser U100 include a minor increase in pulse energy and pulse frequency, and the option of a double pulse setting.
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    K Number
    K022721
    Device Name
    UROPOWER
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Date Cleared
    2003-08-26

    (375 days)

    Product Code
    EXY
    Regulation Number
    876.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    W.O.M. WORLD OF MEDICINE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uropower is a urine flow and volume measuring system intended for lay use to measure the urine volume and flow of men during the course of normal urination. The device is also intended to be used by health care professionals.
    Device Description
    The Uropower is a device intended to measure the urine flow and calculate the volume of males in order to identify micturition disturbances. It is designed to be used by health care professionals and by laymen. The system consists of a base unit, a urinal-flow-transducer and various mount elements. Due to its construction the transducer can be installed in a urinal. The user is guided by instructions shown on the LCD display of the base unit. The urinal flow transducer measures the flow of the urine in accordance with the through-flow-principle, a volume per time measurement. The base unit calculates the total voided volume, maximum flow rate, mean flow rate, total measuring time, time, time to max, flow and medical data like the flow index. All parameters are printed on a thermo card.
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