Search Filters

Search Results

Found 14 results

510(k) Data Aggregation

    K Number
    K033578
    Device Name
    REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS
    Manufacturer
    CLEAR MEDICAL, INC.
    Date Cleared
    2005-07-11

    (606 days)

    Product Code
    NLL
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reloadable Cutters The ClearMedical Reprocessed Reloadable Cutters are intended for transection, resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery. Reloadable Staplers The ClearMedical Reprocessed Reloadable Staplers are intended for the resection of tissues in the alimentary tract and in thoracic surgery.
    Device Description
    The Reprocessed Reloadable Cutters deliver two double-staggered rows of titanium staples while dividing the tissue between the rows. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert. The Reprocessed Reloadable Staplers deliver two double-staggered rows of titanium staples to approximate internal tissues. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert.
    Ask a Question
    K Number
    K033579
    Device Name
    REPROCESSED MULTIPLE CLIP APPLIERS
    Manufacturer
    CLEAR MEDICAL, INC.
    Date Cleared
    2005-07-11

    (606 days)

    Product Code
    NMJ
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reprocessed multiple clip appliers are intended for the ligation of vessels or other tubular structures.
    Device Description
    The reprocessed multiple clip applier is an automatic ligating clip applier. The device is preloaded with a minimum of 10 titanium ligating clips that individually advance after each clip application.
    Ask a Question
    K Number
    K033591
    Device Name
    REPROCESSED TROCARS
    Manufacturer
    CLEAR MEDICAL, INC.
    Date Cleared
    2005-06-03

    (568 days)

    Product Code
    KBG
    Regulation Number
    874.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearMedical Reprocessed Endopath® Tristar® Blunt Tip Surgical Trocar, ClearMedical Reprocessed Endopath® Tristar® Surgical Trocar, and ClearMedical Reprocessed Endopath® Dilating Tip Trocar have application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for minimally invasive instruments.
    Device Description
    Reprocessed endoscopic trocars consist of an obturator and sleeve. The trocar sleeve has a stopcock valve for gas insufflation and a desufflation lever for gas evacuation. The trocar obturator are either flat bladed, pyramidal, or blunt tip. Bladed and dilating tip obturators have a safety shield that exposes the blade during insertion and retract over the tip after the operative cavity has been penetrated.
    Ask a Question
    K Number
    K033592
    Device Name
    REPROCESSED SURGICAL SCISSORS AND GRASPERS
    Manufacturer
    CLEAR MEDICAL, INC.
    Date Cleared
    2004-07-27

    (257 days)

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

    CLEAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearMedical Reprocessed Used, Disposable Endoscopic Scissors and Graspers have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transaction of tissue.
    Device Description
    The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic Scissors and Graspers) is a sterilized SUD. The reprocessed Endopath endoscopic instruments are sterile, single patient use instruments that have a rotating insulated shaft and are designed for use through appropriate surgical trocars. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. Some instruments have a monopolar cautery connector extending from the top of the handle and can be used for electosurgery when properly attached to standard cautery cables and appropriate generators. Other instruments have rachet handles, which allow the instrument jaws to be locked in place. The instrument jaws or scissor blades are activated by compression and release of the ring handles. See instructions for complete mode of operation details. The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic details. The Reprosesses Coasted using EtO sterilization.
    Ask a Question
    K Number
    K033593
    Device Name
    REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS
    Manufacturer
    CLEAR MEDICAL, INC.
    Date Cleared
    2003-11-20

    (7 days)

    Product Code
    NLU
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps are intended to be used during GI procedures for endoscopic tissue sample acquisition. Cold biopsy forceps are intended to be used through an endoscope to remove polyps and/or tissue specimens throughout the alimentary tract. Hot Biopsy Forceps are intended to be used through an endoscope to cauterize and remove polyps and/or tissue specimens throughout the alimentary tract.
    Device Description
    Reprocessed Used Disposable Biopsy Forceps. Reprocessing Biopsy Forceps is performed by Clear Medical to Clear Medical protocol Number 40003. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. Clear Medical is a "third party reprocessor" and reprocesses used, single-use medical devices. Clear Medical, Inc. reprocessed Microvasive, single use, electric and mechanical biopsy forceps. CMI intends to reprocess used disposable hot and cold biopsy forceps manufactured by Micovasive. CMI reprocessed biopsy forceps are disposable unless reprocessed again by Clear Medical, Inc.
    Ask a Question
    K Number
    K031416
    Device Name
    CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF
    Manufacturer
    CLEAR MEDICAL, INC.
    Date Cleared
    2003-07-15

    (71 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLEAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearMedical Blood Pressure Cuff is indicated for use in manual measurement and automatic non-invasive blood pressure (BP) monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual BP measurement The ClearMedical Blood Pressure Cuff is intended as a single patient use item.
    Device Description
    Not Found
    Ask a Question
    K Number
    K012600
    Device Name
    CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
    Manufacturer
    CLEAR MEDICAL, INC.
    Date Cleared
    2002-07-03

    (324 days)

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

    CLEAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The adult Oxisensor, model D-25 and D-25L, is indicated for single patient use when continuous noninvasive artertal oxygen saturation and pulse rate monitoring are required for patients weighing more than 30 kg. The reprocessed ClearMedical/Nellcor D-25/ D-25L Oxisensor is intended as a single patient use transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor is the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of adult patients. The D-25/D-25L oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.
    Device Description
    The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturation and pulse rate. The oxisens of the a the a transmission of functional oxygen saturation and and from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.
    Ask a Question
    K Number
    K012609
    Device Name
    CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25
    Manufacturer
    CLEAR MEDICAL, INC.
    Date Cleared
    2002-07-03

    (324 days)

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

    CLEAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The neonatal/adult Oxisensor, model N-25, is Indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing less than 3 kg or more than 40 kg. The reprocessed ClearMedical/Nellcor N-25 Oxisensor is intended as a single patient use O₂ transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of neonatal and adult patients. The N-25 oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.
    Device Description
    The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturation and pulse rate. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.
    Ask a Question
    K Number
    K012622
    Device Name
    CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20
    Manufacturer
    CLEAR MEDICAL, INC.
    Date Cleared
    2002-07-03

    (324 days)

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

    CLEAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pediatric Oxisensor, model D-20, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing between 10 and 50 kg. The reprocessed ClearMedical/Nellcor D-20 Oxisensor is intended as a single patient use O transducer/accessory sensor to a Nellcor Oximeter system. The role of the sensor the acquisition of patient data which is used by the oximeter in the determination of functional oxygen saturation and pulse rate of pediatric patients. The D-20 oxisensor is used in conjunction with the Nellcor oximeter in a hospital environment where non-invasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate (PR) are required for patients with potentially abnormal pulmonary/circulatory function.
    Device Description
    The ClearMedical/Nellcor Oxisensor is an accessory device to an oximeter monitoring system. The oximeter system is designed for the determination of functional oxygen saturering and pulse rate. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LED's and photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to the laminated envelope is a sensor cable, which terminates in a connector element that connects to the oximeter.
    Ask a Question
    K Number
    K012601
    Device Name
    CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH
    Manufacturer
    CLEAR MEDICAL, INC.
    Date Cleared
    2002-02-06

    (177 days)

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

    CLEAR MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To reduce the incidence of deep vein thrombosis, reduce pain and swelling after injury or surgery and increase arterial blood flow.
    Device Description
    The ClearMedical/Aircast VenaFlow Cuffs are an accessory device to a VenaFlow System which is used for the prevention of deep vein thrombosis. The VenaFlow Cuff is designed with two inflatable bladders that fill with air to provide compression to the legs and feet. A connector tubing system attaches the Cuff to the pump system. The VenaFlow Cuffs are latex-free, made of a polyester-cotton fabric. They are The vehal low Oulls are latest nos, a proximal and distal bladder and polyethylene tubing with polypropylene luer-lock connectors.
    Ask a Question

    Page 1 of 2