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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Applied Medical Technology, Inc.

    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
    K241111
    Device Name
    AMT Suture Passer
    Manufacturer
    Applied Medical Technology, Inc.
    Date Cleared
    2024-07-05

    (74 days)

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

    Applied Medical Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations.
    Device Description
    The AMT Suture Passer is a sterile, single-case use, hand-held suture grasping device. The device features a hypodermic needle through which a suture can be passed and retrieved through another. The retrieval component may be offered in two configurations: a non-magnetic version, and a magnetically assisted version, using a grasper with a magnetized arm. Using either configuration, the AMT Suture Passer provides more flexibility in stitch geometry and approach than traditional U-stitches. The preferred method to introduce the suture is through a separate introducer needle; the AMT Suture Passer Kit with Magnet Assist instrument set bundles the magnetically assisted configuration of the AMT Suture Passer with an introducer needle and two magnetic sutures to create a non-procedure-specific kit. For the magnetically assisted configuration, the magnetized arm of the grasper works in conjunction with a magnetic suture to reduce the technical difficulty of intracorporeal suture retrieval under laparoscopic, endoscopic, radiologic, or ultrasound guidance. This magnet-assist technology is derived from the ATLAS Suture Delivery System (K193612), also manufactured by Applied Medical Technology, which performs the same clinical function and is used in similar clinical applications. Both configurations of the AMT Suture Passer feature identical components, except for the end-effectors, and make use of Luer-lock compatible hubs that allow a syringe to be attached for the purpose of administering contrast through the device. The contrast enters through the Luer hub and exits from the distal end of the needle, which allows the needle position to be verified prior to passing the suture during interventional radiology procedures.
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    K Number
    K222846
    Device Name
    AMT G-Tube Balloon Gastrostomy Feeding Device
    Manufacturer
    Applied Medical Technology, Inc.
    Date Cleared
    2023-12-18

    (453 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Applied Medical Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMT G-Tube Balloon Gastrostomy Feeding Device is indicated to be used as a percutaneous gastrostomy tube. This device will assist in providing nutrition directly into the stomach through a secured (initial placement) or formed (replacement) stoma in a human patient, 10kg or above, who is unable to consume nutrition by conventional means. The AMT G-Tube Balloon Gastrostomy Feeding Device can also deliver medication and allow for decompression of the stomach.
    Device Description
    The Applied Medical Technology, Inc. G-Tube Balloon Gastrostomy Feeding Device (AMT G-Tube) is made of silicone elastomer and is designed for enteral feeding in a gastrostomy tract. The device can be used as a replacement device through a mature stoma tract or for initial placement in a supported stoma tract. The device is offered in several French (FR) sizes ranging from 12 FR to 24 FR. 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 external bolster (preassembled on the AMT G-Tube) acts as a stabilizer to prevent inward migration. The device is sold as sterile and can be placed in an outpatient or home setting by a health care professional or care giver.
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    K Number
    K202539
    Device Name
    Nutriglide(TM) Nasal Feeding Tube
    Manufacturer
    Applied Medical Technology, Inc.
    Date Cleared
    2020-10-29

    (57 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Applied Medical Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NutriGlide™ Nasal Feeding Tube is indicated for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
    Device Description
    The Nutriglide™ Nasal Feeding Tube is a nasal feeding tube available in both sterile and non-sterile ENFit® and legacy configurations featuring a y-port, widening lumen diameter, dissolvable tube tip, and optional stylet with water activated lubricous coating. The device is identical between the ENFit® and legacy configurations but for the y-port which will feature either ENFit® adapters or the legacy ports. Both configurations feature tubing with a unique taper design where the lumen gradually increases from the proximal end (external) to the distal opening (indwelling). This design creates a tube that is smaller near the external y-port and gradually increases to its largest diameter at the distal tip opening where the nutrition/medication exists into the patient's stomach or small intestine. The lubricious dissolvable tip offers increased comfort during placement on the various configurations of both the ENFit® and legacy devices, and then once dissolved it reveals the entire rounded distal opening of the tube, allowing for maximum flow during feeding.
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    K Number
    K193612
    Device Name
    AMT Suture Delivery System
    Manufacturer
    Applied Medical Technology, Inc.
    Date Cleared
    2020-03-12

    (77 days)

    Product Code
    KGC
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Applied Medical Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMT Suture Delivery System is intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days in child, adolescent, and adult populations.
    Device Description
    The Suture Delivery System is a sterile, single use suturing device designed to pass suture percutaneously through tissues in order to anchor the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters. The non-absorbable suture meets requirements established by the United Stated Pharmacopeia (USP) for non-absorbable surgical suture. The suture is provided pre-loaded in a hand-held, manually operated, disposable suture application device. Only the suture and the anti-splay component are intended to remain in place while the wall of the viscous adheres to the abdominal wall; all other components of the delivery system are removed completely and discarded.
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    K Number
    K183508
    Device Name
    Micro Transgastric-Jejunal Feeding Device
    Manufacturer
    Applied Medical Technology, Inc.
    Date Cleared
    2019-03-29

    (101 days)

    Product Code
    KNT, PIF
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Applied Medical Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Micro Transgastric-Jejunal Feeding Device is inchildren and adults who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy. The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.
    Device Description
    The AMT Micro Transgastric-Jejunal feeding device is a single-use feeding tube that provides for simultaneous gastric decompression / drainage and delivery of enteral nutrition into the distal duodenum or proximal jejunum. It enters the stomach through a gastric stoma. The tube in held in place (within the stoma tract) by means of an inflatable balloon and a low-profile external bolster. The external bolster contains two ports; one labeled "JEJUNAL" (glow green) and one labeled "GASTRIC" (white). Incorporated within each port is a one-way valve which is opened by attaching the appropriate AMT Extension Set. AMT Extension Sets are color coded and connect to the feeding and drainage ports. The JEJUNAL (glow green) port is used for feeding into the small intestine. The GASTRIC (white) port is used to drain the stomach with the use of low intermittent suction or gravity drainage. A third port labeled "BAL" is used to inflate and deflate the balloon. The Micro Transgastric-Jejunal Feeding Device is provided sterile (Ethylene Oxide) for prescription use only.
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    K Number
    K182804
    Device Name
    Traditional Length GJ Feeding Device
    Manufacturer
    Applied Medical Technology, Inc.
    Date Cleared
    2019-03-01

    (150 days)

    Product Code
    KNT, PIF
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Applied Medical Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Traditional Length GJ Feeding Device is indicated for use in adult, adolescent, children, and infants over 10kg who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectorny or gastrectomy. The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.
    Device Description
    The Traditional Length GJ Feeding Device is a single-use feeding tube that provides for simultaneous gastric decompression / drainage and delivery of enteral nutrition into the distal duodenum or proximal jejunum. It enters the stomach through a surgically-created gastric stoma. The multi-lumen tubing is marked with a graduated scale and held in place by means of an inflatable internal retention balloon and a sliding external bolster. The external tri-port is overmolded onto the tubing and contains three ports: one large port for administering nutrition/medication in the jejunum labeled "JEJUNAL," one large port for gastric decompression/drainage labeled "GASTRIC," and one smaller port housing the balloon fill valve labeled "BAL." The tri-port component of the Traditional Length GJ Feeding Device is offered in two variations: a legacy model and an ENFit® model designed to ISO 80369-3. Both variations of the device are identical except for the design of the tri-port component configurations. - The tri-port of the legacy model has two large silicone funnel ports, and a small port to fill 1. the retention balloon. The JEJUNAL and the GASTRIC ports have individual attached silicone straps and plugs intended to independently close each funnel when not in use. The BAL port houses a small, MR conditional balloon fill valve. - 2. The tri-port of the ENFit® model has 2 large ports and one small port akin to the legacy model, but with a twist-lock thermoplastic male ENFit® connector housed in each the JEJUNAL and the GASTRIC funnel ports. The ENFit® connectors are compliant to ISO 80369-3. The JEJUNAL and the GASTRIC ENFit® ports have individual attached tethers and plugs intended to independently close each ENFit® port when not in use. The BAL port houses an MR safe balloon fill valve. Both the legacy and the ENFit® variations of the Traditional Length GJ Feeding Device are offered in different French sizes. The gastric length of both variations of the Traditional Length GJ Feeding Device is adjustable, depending on where the sliding external bolster is placed along the multi-lumen tubing. Various jejunal lengths are available. The distal portion of only the 16Fr and 18Fr jejunal tubing contains an anti-kink design using a metal spring. At the distal end of every tube, a silicone tip is attached to the device through which a non-absorbable suture is attached. The Traditional Length GJ Feeding Device is provided sterile (Ethylene Oxide) for prescription use only.
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    K Number
    K180026
    Device Name
    Bowel Management Device, Bowel Management Irrigation Set
    Manufacturer
    Applied Medical Technology, Inc.
    Date Cleared
    2018-06-01

    (149 days)

    Product Code
    KNT, EXD, PIF
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Applied Medical Technology, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bowel Management Device is intended to instill fluids through a stoma into the colon to promote evacuation of the contents of the lower bowel through the anus and is intended to be an aid in the management of fecal incontinence. The catheter is placed and maintained in a percutaneously prepared opening, such as a cecostomy or appendicostomy. The Bowel Management Device is intended to be used in children and adults. The Bowel Management Irrigation Set is intended to allow connection between a compatible bowel management device and the delivery tubing of an irrigation/enema bag system.
    Device Description
    The Bowel Management Device is an indwelling low profile catheter used to promote evacuation of the lower bowel through antegrade colonic flushing. It consists of an internal retention balloon and a flexible external bolster with a balloon fill-valve, interlock irrigation port, and safety plug. The catheter is inserted through the stoma and into the colon and is secured by the internal retention balloon when inflated. The Bowel Management Irrigation Set has a connector on one end that connects to the interlock on the catheter and an adapter on the other end to connect to the irrigation/enema delivery system. Fluids can then be instilled directly into the colon through the catheter.
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    K Number
    K161413
    Device Name
    Low Profile Balloon Feeding Device
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2017-02-09

    (262 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED MEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Low Profile Balloon Feeding Device is indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma. The Low Profile Balloon Feeding Device is intended for all age groups.
    Device Description
    The Low Profile Balloon Feeding Device is used to provide nutrition, medication, and decompression access into the stomach through a secured (initial placement) or formed (replacement) stoma. The Low Profile Balloon Feeding Device consists of an external bolster, feeding catheter, and internal retention balloon, similar to the predicate devices. The feeding catheter is inserted into the stomach through a stoma and is held in place with an internal retention balloon. The device can have an MR Conditional balloon fill-valve or will be MR Safe when assembled with the Invisi-Valve. The devices are provided in a number of sizes to accommodate different stoma diameters and lengths and can have either a blunt or tapered tip balloon. The catheter tubes range in diameter from 10Fr to 24Fr, which is the same as the primary predicate. The stoma lengths are available in a wider range of options, from 0.5cm to 10.0 cm.
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    K Number
    K150034
    Device Name
    AMT Enteral Transition Adapters
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2015-06-09

    (151 days)

    Product Code
    PIO
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPLIED MEDICAL TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMT Enteral Transition Adapters are intended to facilitate enteral specific connections between AAMI/CN3(PS) compliant connectors and non ISO 80369-1 compliant legacy enteral connectors.
    Device Description
    New standard ISO-80369-1 is pushing feeding tube manufacturers to transition current extension set designs to incorporate enteral only connectors. Most enteral feeding devices currently on the market utilize luer slip or catheter tip connectors to connect enteral giving sets and syringes to enteral receiving sets. Standard luer slip and catheter tip connectors raise risk levels for patients as devices outside of the enteral market use similar connections, including IVs. Therefore, the ISO/IEC 80369 series was developed to help reduce the possibility of misconnections across different medical fields. The FDA recently cleared an updated AMT enteral extension set in 510(k) K142989. This extension set remains identical to our previously marketed device, but includes Enfit connectors. However, launching a enteral extension sets with Enfit connectors will not be simultaneous across all manufacturers and distributors. Therefore, transition adapters are necessary for a limited time. As the new Enfit connectors are not backwards compatible with current luer and bolus connections currently used for enteral products, AMT has designed several transition adapter configurations to help users make the switch to the new connections. AMT estimates that there will be a time of at least a year and possibly up to three years where users and distributors will still have access to enteral devices with luer / bolus connectors. The transition adapters AMT has designed in this 510(k) will allow users to use their old giving/receiving sets until the market is flushed of old inventory. The AMT Enteral Transition Adapters come in 5 configurations and are made up of 5 separate components. The five configurations include: • Male Enfit to Male Luer Adapter • Female Enfit to Female Luer Adapter • Female Enfit to Y-Port (Bolus/Luer) Adapter • Female Enfit to Bolus Adapter • Male Enfit to Christmas-tree Adapter These 5 transition adapter configurations will allow AMT to offer users with options for all of the common enteral connectors currently on the market. All components and materials have been previously cleared in 510(k)s for similar use. It is planned to include these transition adapters kitted with enteral devices previously cleared through the 510(k) process, as well as selling the adapters as stand-alone items.
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