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510(k) Data Aggregation

    K Number
    K240514
    Device Name
    AMT Low-Profile Suprapubic Catheter & Drainage Set
    Manufacturer
    Applied Medical Technology, Inc.
    Date Cleared
    2024-11-01

    (253 days)

    Product Code
    KOB
    Regulation Number
    876.5090
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated for patients 7 years of age and older with lower urinary tract dysfunctions such as neurogenic bladder dysfunction or urethral obstruction or who are severely disabled or requiring constant care. The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated to be used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks. The AMT Low- Profile Suprapubic Catheter is intended to be placed directly into the bladder through a secured (initial placement) or formed (replacement) stoma.
    Device Description
    The Applied Medical Technology, Inc. (AMT) Low-Profile Suprapubic Catheter & Drainage Set (LPSPC) consists of two primary assemblies. The LPSPC is identical in materials and manufacturing processes to the Low-Profile Balloon Feeding Device cleared in K161413 for a different indication. The Suprapubic Catheter is used to provide urinary diversion and drainage through the lower abdomen, placed and maintained in a percutaneously prepared cystostomy opening. The Drainage Set is intended to allow a connection between the suprapubic catheter device and a urinary collection bag system. The device is designed for bladder drainage by way of a secured (initial placement) or formed (replacement) cystostomy tract and may be used for irrigation. Patients may include: any user with urethral trauma, those who require long-term catheterization and urethral catheterization is intolerable, or those with a spinal cord injury and an inability to self-catheterize who may find the suprapubic method simpler to manage. The LPSPC is a urinary drainage device made principally of silicone elastomer. The device consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlocking irrigation port, and safety plug. The catheter is inserted through the stoma and into the urinary bladder and is secured by the internal retention balloon. The device is offered in various sizes to accommodate different stoma diameters and lengths. On the shaft near the end is located a balloon which, when properly inflated, acts as an internal stabilizer preventing outward displacement through the stoma in the abdominal wall. The balloon is inflated through a separate inflation valve located in the external portion of the device. The external profile of the device acts as a stabilizer to prevent inward migration and affords the user the ability to connect a provided Drainage Set. The Drainage Set is identical in material and manufacturing process to certain configurations of the Irrigation Set included with the AMT Bowel Management Device previously cleared in K180026. The right-angle connector of the Drainage Set is compatible with the interlock on the LPSPC and is used to direct fluids drained from the bladder, through the catheter, and into a separate urinary collection bag. The AMT Low-Profile Suprapubic Catheter & Drainage Set may optionally be marketed with a Foley Insertion Tray accessory. If included, the accessory would be a legally marketed Foley Insertion Tray, such as: - AMSure Foley Insertion Tray (previously cleared Class II, Product Code FCM, K030664) - Bardia Foley Insertion Tray (registered Class II, Product Code OHR, 510(k) exempt) - Dynarex Foley insertion Tray without Catheter (registered Class II, Product Code OHR, 510(k) exempt) The device is sold as sterile and can be initially placed in an outpatient-setting by a health care professional. The device may be replaced in an outpatient-setting or home setting by a health care professional or care giver.
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    K Number
    K211934
    Device Name
    APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2022-11-10

    (506 days)

    Product Code
    FAD, FFA
    Regulation Number
    876.4620
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide percutaneous drainage of abscess fluid, biliary, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collection. The vanSonnenberg™ Sump Catheter is designed for use as a percutaneously placed drain for intra-abdominal fluid collections. Such conditions include abscesses, cysts, pseudocysts, bilomas, seromas, urinomas, or any loculated fluid collection.
    Device Description
    All Purpose Drainage catheters are designed to provide constant, unobstructed fluid drainage from various fluid accumulations to an external and/or internal collection sites and to ensure stability during treatment. These ends are met through the choice of drainage material and by incorporating a secure fixation method in the drainage site (internally by pig-tail or "J" style tips and externally, by means of suture or adhesive). Percutaneous placement is accomplished with radiological guidance. Select Boston Scientific All Purpose Drainage catheters are coated with a hydrophilic material, Glidex™ , for the reduction of surface friction during placement. Some of these catheters are also available with a biocompatible, distal tip (Temp-Tip™). The tip's internal diameter allows the guidewire to direct the tip for accurate catheter placement; however, soon after placement, the Temp-Tip™ material dissolves, allowing the full diameter of the catheter lumen to contribute to site drainage. All Purpose Drainage catheters are manufactured with one of two types of resins, Flexima or Percuflex. - Flexima is a biocompatible polyurethane (Tecoflex) known for its flexibility, strength, and kink resistance. Flexima comes in durometers ranging in Firm, Regular and Soft and uses a radiopacifier for visualization under fluoroscopy. - Percuflex is an ELVAX™ 460, ethylene vinyl acetate (EVA) copolymer for patient comfort. This material is available in firm (white in color) and regular (blue in color) durometers. The firmer durometers provide more pushability during device placement. A radiopaque additive, bismuth subcarbonate, incorporated throughout the catheter tube also aids radiopacity and percutaneous placement.
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    K Number
    K191498
    Device Name
    Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
    Manufacturer
    Cook Incorporated
    Date Cleared
    2020-01-29

    (238 days)

    Product Code
    LJE, KOB
    Regulation Number
    N/A
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cook-Cope Loop Nephrostomy Set: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage. Ultrathane Nephrostomy Set with Mac-Loc: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage. Ultrathane Suprapubic Set with Mac-Loc: The Ultrathane Suprapubic Set with Mac-Loc is used to provide bladder drainage by percutaneous placement of a loop catheter.
    Device Description
    The bundled submission includes the Cook-Cope Loop Nephrostomy Set, Ultrathane® Nephrostomy Set with Mac-Loc®, and the Ultrathane® Suprapubic Set with Mac-Loc® - . Cook-Cope Loop Nephrostomy Set and Catheter: The catheter is placed using standard percutaneous nephrostomy techniques into the kidney. The catheter is then secured in place by pulling the suture taut to create the distal retention loop, wrapping around the catheter shaft and knotting the suture. The latex is then folded over the suture and the excess suture is cut off. The catheter is kept in place within the patient using a retention disc. - . Ultrathane Nephrostomy Set with Mac-Loc: The catheter is placed using standard percutaneous nephrostomy techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the monofilament, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using a retention disc. - Ultrathane Suprapubic Set with Mac-Loc: The catheter is placed using standard . suprapubic techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the tether, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using the enclosed StatLock device. The subject percutaneous drainage catheter sets consist of a flexible tube with an open distal tip and drainage holes. The distal end of the subject devices has either a Mac-Loc locking loop or a cope loop. A Mac-Loc locking loop mechanism secures the distal catheter loop configuration by means of a nylon monofilament. After the catheter is placed in the desired location, the nylon thread is pulled tight to form the distal loop configuration. Then the locking cam lever can be pushed down to snap into position, thereby locking the distal loop in position. The cope loop configuration is formed by pulling back the suture, and then the loop can be locked in place by sliding a latex sleeve over the suture. Some catheter sets have a radiopaque marker to aid the user in placement. The proximal hub assembly of the devices provides a Luer lock hub to allow the user to connect to a fluid collection device (not subject of this submission). Accessories include introducing catheters, catheter securing devices, needles, cannulas, stylets, dilators, and wire guides.
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    K Number
    K181097
    Device Name
    Cook Cystostomy Catheter Set
    Manufacturer
    Cook Incorporated
    Date Cleared
    2019-01-18

    (267 days)

    Product Code
    KOB
    Regulation Number
    876.5090
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cook® Cystostomy Catheter Set is used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks.
    Device Description
    The Cook® Cystostomy Catheter Set is composed of a single-lumen silicone catheter available in 8 to 12 French with a working length of 54 centimeters, a trocar stylet with access sheath having an outer diameter of 10 to 14 French with a length of either 11 or 11.2 centimeters, a drainage adapter with stopcock available in 12 to 16 gauge and a soft low-profile silicone catheter support with pull tie. The set is supplied sterile, intended for one-time use only, and packaged in a peelopen pouch with a three-year shelf life.
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    K Number
    K182709
    Device Name
    One-Step Suprapubic Introducer
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-12-26

    (90 days)

    Product Code
    KOB
    Regulation Number
    876.5090
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The One-Step Suprapubic Introducer is used for introducing a drainage catheter suprapubically into the bladder.
    Device Description
    The One-Step Suprapubic Introducer is comprised of a stainless steel trocar stylet needle and a dilator with a peel-away sheath. The trocar stylet needle is 20 centimeters (cm) long with a trocar beveled tip at the distal end of the device. The dilator is 14-22 French (Fr) and 18-19 cm in length. The peel-away sheath is 14-22 Fr and 17 cm in length. The three components are designed to fit together to form a single assembly.
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    K Number
    K182066
    Device Name
    O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-10-30

    (90 days)

    Product Code
    KOB
    Regulation Number
    876.5090
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O'Brien Suprapubic Peel-Away Access Set is used for introducing a drainage catheter suprapubically into the bladder. The Cook® SP Tube Introducer Set is used for introducing a drainage catheter suprapubically into the bladder.
    Device Description
    The O'Brien Suprapubic Peel-Away Access Set includes a peel-away sheath, dilator, trocar needle and wire guide. The peel-away sheath is available in even-numbered French sizes ranging from 16.0 to 20.0 and measures 22 centimeters in length. Dual knobs allow the sheath, manufactured from thick wall radiopaque polytetrafluoroethylene material, to be peeled back and removed. The Cook SP Tube Introducer Set is comprised of a 20 Fr sheath which is 15 cm in length, an introducer that fits within this sheath, two dilators, a wire guide and needle.
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    K Number
    K140085
    Device Name
    UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
    Manufacturer
    COOK INCORPORATED
    Date Cleared
    2014-11-18

    (309 days)

    Product Code
    FEW, KOB, LJE
    Regulation Number
    876.5090
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Universa® Loop Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system. The Universa® Malecot Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
    Device Description
    The Universa® Percutaneous Drainage Catheter Sets include introductory and exchange sets available with either a loop (6-14 Fr) or a Malecot catheter (8-24 Fr). Suprapubic sets are available with a Malecot catheter (8-16 Fr). Each set includes a drainage catheter and connecting tube, and may also include straightening stylets, trocar needle with obturator, hollow needle, wire guide, dilators, silicone retention disc with pull tie, or one-way stopcock. The devices will be supplied sterile and intended for one-time use.
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    K Number
    K132890
    Device Name
    SUPRAPUBIC CATHETER AND INTRODUCER SET
    Manufacturer
    MEDIPLUS LTD.
    Date Cleared
    2014-01-17

    (123 days)

    Product Code
    KOB
    Regulation Number
    876.5090
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Suprapubic Catheter and Introducer Set is indicated for drainage of the bladder through a needle puncture or stab wound over the bladder. For use no greater than 29 days.
    Device Description
    Suprapubic catheters are Foley catheters that are placed with an introducer through a needle puncture or stab wound over the bladder to allow bladder irrigation and / or drainage of the bladder. They are available in two (2) tip styles, closed and open tip, The introducer kit includes a number of components including: Scalpel, Syringe, 18 gauge needle, Dilator and Peelable sheath, and Guidewire
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    K Number
    K120127
    Device Name
    SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
    Manufacturer
    SWAN VALLEY MEDICAL, INCORPORATED
    Date Cleared
    2012-10-26

    (283 days)

    Product Code
    KOB, FEX
    Regulation Number
    876.5090
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Swan Valley Medical Transurethral Suprapubic endo-Cystostomy (T-SPeC®) Surgical System is intended for suprapubic bladder catheterization (cystostomy) and drainage. The catheter should not be allowed to remain indwelling for more than 29 days.
    Device Description
    The T-SPeCTM Surgical System is, in effect, a sterile suprapubic catheter and accessory kit consisting of a) a suprapubic catheter; b) a catheter punch instrument used to create a cystostomy and place the suprapubic catheter; and c) a piston syringe to fill the catheter balloon after placement.
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    K Number
    K101937
    Device Name
    HYBRID TROCAR SYSTEM
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    2010-08-11

    (30 days)

    Product Code
    GCJ, FBQ
    Regulation Number
    876.1500
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The endoscopic instruments presented in this submission are for use in laparoscopy (abdominal and gynecological surgery) for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments.
    Device Description
    Aesculap's Hybrid Trocar System can be used in laparoscopic general surgery. gynecology, and urology. The trocars are made from biocompatible materials. They are available as reusable in 3.5, 5, 10 or 12mm diameter with lengths of 60, 110, and 150mm. The trocars are offered with or without a stopcock, and threaded or smooth. The devices are color coded for easy identification.
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