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510(k) Data Aggregation

    K Number
    K102141
    Device Name
    COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2011-05-06

    (281 days)

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

    COOK UROLOGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used for the treatment of abscesses and cysts of the Bartholin gland.
    Device Description
    The Word Catheter-Silicone Bartholin Gland Balloon Set is used for treatment of abscesses and cysts of the Bartholin gland. The Word Catheter-Silicone Bartholin Gland Balloon Set is a 3 ml balloon catheter which is 5.5 cm in length and constructed of silicone. The catheter is sold with a 1" 21 gauge needle and a scalpel with a # 1 blade is used to lance the Bartholin gland cystlabscess, the syringe with needle is used to inflate the balloon catheter, and the catheter is placed in the cyst or abscess remaining for up to 28 days to allow the duct to re-epithelialize. The devices are provided sterile and are intended for one time use.
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    K Number
    K091767
    Device Name
    3 WAY SILICONE FOLEY BALLOON CATHETER
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2009-10-09

    (114 days)

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

    COOK UROLOGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or by Nephrostomy.
    Device Description
    The 3 Way Silicone Foley Balloon Catheter is composed of a silicone tube with an imbedded radiopaque blue stripe, a silicone balloon and polyvinylchloride valve. The tube has three lumens, one lumen for urinary drainage which is to be connected to urine collection container, one lumen with two-way valve for inflation/deflation of Foley balloon and one lumen for irrigation of bladder. Catheter is available in 16, 18, 20, 22, 24, 26 French with 30 cc balloon. Catheter is available in open or closed end. Open end allows for use of wire quide available separate). The 3 Way Silcone Foley Balloon Catheter is intended to be used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or Nephrostomy. The devices are provided sterile and are intended for one time use.
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    K Number
    K082939
    Device Name
    COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2009-09-03

    (336 days)

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

    COOK UROLOGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cook® Fetal Membrane Manipulator is indicated as an adjunct to a cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage.
    Device Description
    The Cook® Fetal Membrane Manipulator is used to atraumatically push and position emerging fetal membranes back through the cervical canal and into the uterus to facilitate a successful cervical cerclage procedure in order to prolong pregnancy to a successful delivery. The Cook® Fetal Membrane Manipulator is intended to be used as an adjunct to a cervical cerclage needle for replacement of fetal membranes and temporary occlusion of the internal cervical os during cervical cerclage. The Cook® Fetal Membrane Manipulator is comprised of a November polycarbonate dual lumen catheter with a silicone balloon. The balloon catheter assembly includes a Check-Flo-adapter. The device is provided sterile and intended for one-time use.
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    K Number
    K082066
    Device Name
    TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2008-11-07

    (108 days)

    Product Code
    HFE
    Regulation Number
    884.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    COOK UROLOGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to obtain endometrial cytological and histological samples.
    Device Description
    The Tao Brush™ I.U.M.C. Endometrial Sampler is a brush assembly fitted inside a shaft. A coaxial sheath promotes sample protection and there are positioning marks on the end of the shaft. The brush head procures and adequate representative sample of the endometrial and the tip protects the patient from abrasion. The devices are provided sterile and are intended for one time use.
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    K Number
    K082536
    Device Name
    COOK WIRE GUIDES
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2008-10-27

    (55 days)

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

    COOK UROLOGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cook Urological Wire Guides are used for ureteral access, to establish a tract, and assist in the placement, replacement, and exchange of devices during urological procedures. For the Roadrunner Wire Guides the intended use also includes use in a torturous or kinked ureter, traversing a large stone in route to the kidney, or in cases demanding enhanced control and high radiopacity. These wire guides are not intended for PTCA use.
    Device Description
    Cook Wire Guides are designed to be used during Urological procedures where use of a wire quide is warranted. The wire quides consists of a single piece of wire tightly wound into coils from tip to tip. Two additional wires are present inside the coils, one called a flat safety wire and the other a round wire. Some of the wire guides are coated with a polymer sleeve, some with PTFE, some are stainless steel, and some are hydrophilically coated. Several variations of Cook Wire Guides are available. The wire quided sterile in peel-open packages and are intended for onetime use.
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    K Number
    K082319
    Device Name
    INJEKT FILIFORM INJECTION NEEDLE
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2008-09-25

    (43 days)

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

    COOK UROLOGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to inject legally marketed therapeutic agents into the genitourinary system, most specifically for vesicoureteral reflux (VUR) in the pediatric population and for bladder neck injection for the population as a whole.
    Device Description
    The INJEKT™ Filiform Injection Needle consists of a needle and an outer sheath with a filiform tip. Hash marks on the outside of the needle are used to assess proper depth of placement. The filiform tip of the needle acts as a landmark for easier access to precise injection. The needle exits the side of the device to allow precise injection and assures additional safety for the patient against inadvertent stick when the needle is retracted. The devices are provided sterile and are intended for one time use.
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    K Number
    K080525
    Device Name
    COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2008-04-17

    (51 days)

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

    COOK UROLOGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for use in fragmentation of urinary calculi and soft tissue applications. The Cook® Odyssey Holmium Laser System is indicated for use in Urinary, Gastroenterology, Pulmonary, Gynecology, and General Surgery procedures where fragmentation of stones and soft tissue incision, hemostasis, vaporization and ablation are indicated.
    Device Description
    The Cook® Odyssey Holmium Laser System is used in fragmentation of urinary calculi and soft tissue applications. The Cook® Odyssey Holmium Laser System is a pulsed holmium YAG laser emitting laser radiation at 2100 nm with a 30 Watt maximum average power. The normal wavelength is strongly absorbed by water for tissue ablation with minimal lateral thermal damage. In the case of laser lithotripsy, laser energy vaporizes water in the calculus causing it to crack into small enough particles to pass easily. The system is a completely enclosed transportable unit.
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    K Number
    K073496
    Device Name
    OPTILITE HOLMIUM LASER FIBERS
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2008-01-23

    (42 days)

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

    COOK UROLOGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd:YAG, Argon, Diode, Ho:YAG and ER:YAG wavelengths for the indications for which the lasers have been cleared.
    Device Description
    The OptiLite™ Holmium Laser Fibers are intended to be used with legally cleared laser systems to deliver laser energy. The fiber delivery system is typically used in conjunction with a rigid or flexible endoscope to access the surgical site. The laser fibers work on the principle of total internal reflection. Laser energy is focused into a glass silica fiber at the proximal end and traverses the length of the fiber by means of total reflection. The fiber is able to contain the laser beam and funnels the laser energy from the proximal end to the distal end.
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    K Number
    K072521
    Device Name
    COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2007-11-20

    (74 days)

    Product Code
    FFS, FAJ, FED, FGA, FGB, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    COOK UROLOGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath are intended for use during cystoscopic, nephroscopic, laparoscopic and ureteroscopic procedures. The Cook® Fiber Optic Bundle is intended for direct visualization of body cavities or organs. The Flexor® Deflecting Access Sheath is used to provide access as well as protection for the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation.
    Device Description
    The Cook® Fiber Optic Bundle is a small diameter fiber optic consisting of inner illuminating fibers and an outer imaging fiber bundle contained in a plastic sleeve. At one end of the imaging bundle is a distal lens and at the other end a fixed eyepiece. The distal lens system focuses an image of the target area under observation onto the tip of the optical imaging fiber bundle. The image is then transmitted to an adjustable focus eyepiece or video adapter at the proximal end of the fiber optic. The eyepiece or video adapter may be connected to a standard video camera to allow the image to be viewed on a video monitor. The light transmitting optical fibers used for illumination have a separate adapter which couples to the external light source. The Fiber Optic Bundle is 2.8 French and available in lengths ranging of 115 and 150cm. The fiber optics are supplied sterile and are intended for up to 10 uses and may be sterilized or disinfected by liquid immersion. The Flexor® Deflecting Access Sheath is a single use sterile dual lumen access sheath that is used to provide access as well as protection of the Cook® Fiber Optic Bundle and has a second working channel for passage of additional instrumentation. The Flexor® Deflecting Access Sheath consists of a tapered dilator and a dual lumen sheath. The sheath is hydrophilically coated, which is activated when wetted. The sheath is attached to a handle assembly which when manipulated allows the tip of the sheath to deflect. When assembled, the Fiber Optic Bundle and sheath act in a manner similar to a flexible endoscope. Because the sheath is deflectable and the Fiber Optic Bundle is flexible, the user is able to position the Fiber Optic Bundle to the desired site in the appropriate body cavity or organ. The sheath has two lumens which allows one lumen to be an access channel for Endoscopic instrumentation and the second lumen to be used as an access port for the fiber optic bundle. The Flexor Deflecting Ureteral Access Sheaths will be available in 45 and 75 centimeter lengths. The Flexor® Deflecting Ureteral Access Sheath will be available in 45 and 75cm lengths. The outside diameter is 15 French. The large lumen's inside diameter is 8.85 French and the inside diameter of the smaller lumen is 3.15 French. When assembled with the Cook® Fiber Optic, the Flexor® Deflecting Access Sheath provides protection for the Cook® Fiber Optic Bundle and deflects up to 180°. The Cook® Fiber Optic Bundle and Flexor® Deflecting Access Sheath will be sold sterile as sets as well as sterile single order items.
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    K Number
    K061371
    Device Name
    SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2006-08-17

    (92 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    COOK UROLOGICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing.
    Device Description
    Sydney IVF Sperm Cryopreservation Buffer consists of an aqueous solution intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing. The IVF technician will use the buffer to cryopreserve washed spermatozoa, including MESA (microsurgical epididymal sperm aspiration) and TESA (testicular sperm extraction) samples.
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