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510(k) Data Aggregation

    K Number
    K243602
    Device Name
    Arthrex Spine Endoscope
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2025-05-16

    (176 days)

    Product Code
    HRX, GCJ
    Regulation Number
    888.1100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications remain unchanged from pre-pandemic COVID-19 vaccines for use in individuals 6 months of age and older.
    Device Description
    HPE 8570B 50 Ohm Programmable Step Attenuator, DC to 18 GHz
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    K Number
    K242417
    Device Name
    VECTR – Video Endoscopic Carpal Tunnel Release System
    Manufacturer
    Rafael Medical Devices, LLC
    Date Cleared
    2024-12-11

    (118 days)

    Product Code
    HRX, EMF
    Regulation Number
    888.1100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VECTR - Video Endoscopic Carpal Tunnel Release System is in minimally invasive ligament or fascia release surgeries, such as: · Carpal tunnel release in the wrist · Cubital tunnel release in the elbow
    Device Description
    The VECTR – Video Endoscopic Carpal Tunnel Release System is composed of a handpiece (5200-01) and a proprietary tablet (5200-90). The handpiece is an arthroscopic unit with an integrated surgical knife. It is intended for minimally invasive ligament or fascia release in endoscopic carpal tunnel release (ECTR) surgery. The proprietary tablet is a registered class I medical device that is commercially available. The handpiece is a single-use disposable device that combines the traditional manual surgical knife with an arthroscope all in one. It is fully integrated into a single unit and consists of a functional tip (surgical knife), live-action camera, light, cannula, and cord to connect to the proprietary tablet. The surgical knife can be used to sever tendons, ligaments, or fascia in the joints or limbs and is able to be protracted or retracted via a slide switch on the side of the handpiece. During procedures, surgeons will introduce the device through incisions made in the patient's wrist. Once inside, the camera and light are used to visualize the surgical environment on the proprietary tablet. Once the surgeon has maneuvered the device into the desired location, the blade can be actuated and the ligament can be cut. Once cut, the surgeon will withdraw the blade and remove the device.
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    K Number
    K243020
    Device Name
    MIDASVu
    Manufacturer
    IntraVu, Inc.
    Date Cleared
    2024-12-02

    (66 days)

    Product Code
    HRX, GCJ
    Regulation Number
    888.1100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MIDASVu is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.
    Device Description
    MIDASVu is an advanced imaging system comprised of sterile, single-use scopes (0° and 30° viewing angle) and a reusable tablet. The scopes include camera and image capture features with LED light source. The distal tip of the scopes contains the camera, illumination, and imaging optics. The scopes are available in three lengths: 60mm, 90mm, and 120mm. The scopes and tablet work in concert as a system to acquire, display and record an intra-articular image as well as store images and video taken during the procedure.
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    K Number
    K241401
    Device Name
    Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    2024-08-15

    (90 days)

    Product Code
    GCJ, FSY, HRX
    Regulation Number
    876.1500
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Connected OR Hub with Device and Voice Control: The use of the Connected OR Hub with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the Connected OR Hub with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device. SDC4K Information Management System with Device and Voice Control: The use of the SDC4K Information Management System with Device and Voice Control is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.
    Device Description
    The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected devices both wired and wirelessly. The Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control consists of the following components: - 1) Base Console which includes: - a) Medical Device Data System (MDDS) functionalities - b) Optional Device Control feature - c) Optional Voice Control feature - d) Optional Video Image Processing (VIP) feature - 2) Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control) - 3) Voice Control Package (software activation USB dongle and a wireless headset and base station) - 4) Video Image Processing package (software activation USB dongle) - 5) Connected OR Spoke (MDDS)
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    K Number
    K233254
    Device Name
    TELIGEN System Navigation Ready Instruments
    Manufacturer
    DePuy Synthes
    Date Cleared
    2024-06-14

    (260 days)

    Product Code
    OLO
    Regulation Number
    882.4560
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TELIGEN Navigation Ready Instruments: The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine. The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. The navigation feature is used in surgical spinal procedures, in which: · the use of stereotactic surgery may be appropriate, and · reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays. These procedures include but are not limited to spinal fusion. TELIGEN Clear and TELIGEN Access Probe, when used with UNAS Navigation Rings, can be precalibrated with: - · the VELYS Spine System using the VELYS Spine Instrument Arrays, - · the Brainlab Navigation System using the UNAS Arrays. TELIGEN Access Probe in conjunction with UNAS can also be manually calibrated with other navigation systems, using tracking arrays supplied by the navigation system manufacturer. The TELIGEN Access Probe is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for location and identification during surgery. Discectomy Navigation Ready Instruments: The Discectorny Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures to facilitate disc space preparation, including discectomy or bony resection. These are indicated for use in surgical spinal procedures, in which: - · the use of stereotactic surgery may be appropriate, and · reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy using a navigation system and associated navigation arrays. These procedures include but are not limited to spinal fusion. The Discectomy Navigation Ready Instruments can be pre-calibrated with the VELYS Spine System (only for TELIGEN Graft Delivery Cannula and the curettes) as well as the Brainlab Navigation System.Universal Navigation Adaptor Set: The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which: · the use of stereotactic surgery may be appropriate, and · reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays. These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instruments, when used with UNAS, can be: · pre-calibrated with the VELYS Spine System using VELYS Spine System Instrument Arrays, - · pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
    Device Description
    TELIGEN Navigation Ready Instruments TELIGEN Navigation Ready Instruments are part of TELIGEN Kits. The TELIGEN Kits are sterile, single use kits intended for use in surgical spinal procedures allowing for access, visualization, discectomy, graft delivery, navigation and peripheral motor nerve stimulation. The TELIGEN Kits include a camera, ports and port holder, TELIGEN Clear, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments. Additionally, the TELIGEN Procedure Kit Pro includes an Access Probe. TELIGEN Access Probe and TELIGEN Clear are part of the DePuy Synthes Navigation Ready Instruments Portfolio and are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling. Discectomy Navigation Ready Instruments The Discectomy Navigation Ready Instruments are reusable instruments used for disc space preparation, including discectomy or bony resection. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS) and associated navigation arrays. For further details on UNAS, refer to the UNAS labeling. Universal Navigation Adaptor Set The Universal Navigation Adaptor Set (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments. The UNAS can only be used with the VELYS Spine System as well as Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes: - Brainlab compatible UNAS Navigation Arrays, - . VELYS Spine/Brainlab compatible Navigation Rings and - Medtronic compatible Navigation Ring ST. ● The Navigation Rings and Navigation Ring ST mate with compatible DePuy Synthes Navigation Ready Instruments. These instruments include implant site preparation and implant insertion instruments as well as access and discectomy instruments. When the VELYS Spine/Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument: - . VELYS Spine System Instrument Array can be attached and the instrument can be used with the VELYS Spine System as pre-calibrated instrument, or - . UNAS Navigation Array can be attached and the instrument can be used with the Brainlab Navigation System as either a manually calibrated and/or pre-calibrated instrument. When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation Navigation System.
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    K Number
    K241008
    Device Name
    Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)
    Manufacturer
    Relign Corporation, Subsidiary of Zimmer Biomet
    Date Cleared
    2024-05-08

    (26 days)

    Product Code
    GEI, HRX
    Regulation Number
    878.4400
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tricera™ Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Tricera™ Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Tricera™ Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.
    Device Description
    The device description and principles of operation for the modified devices are equivalent to the device description of the predicate devices cleared per Primary Predicate-K233493 and additional predicate-K162770. A brief device description of the subject devices is provided in the table below. | Device | Description | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Curved Standard Ball<br>Burr XL, 5.0mm | An arthroscopic burr that provides abrasion, resection, debridement, and removal of bone. The Curved Dynablator XL is specifically designed for use in hip joints with a spherical ball burr and bent outer tube for access to hip pathology. | | Curved Standard<br>Shaver XL, 4.2mm | An arthroscopic shaver that provides resection and removal of soft tissue. The Curved Dynablator XL is specifically designed for use in hip joints with a bent outer tube for access to hip pathology. | | Curved Dynablator XL | An arthroscopic RF probe that provides removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels. The Curved Dynablator XL is specifically designed for use in hip joints with a bent outer tube for access to hip pathology. |
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    K Number
    K233800
    Device Name
    Vertos mild Device Kit (MDK-0002)
    Manufacturer
    Vertos Medical Inc
    Date Cleared
    2024-05-06

    (159 days)

    Product Code
    HRX, CLA, HAE
    Regulation Number
    888.1100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vertos Medical mild Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.
    Device Description
    The Vertos Medical mild Device Kit is a sterile, single-use device. The mild Device is composed of surgical tools consisting of one each of the following components: mild Initiator, mild Access Auger, mild Bone Rongeur, and mild Tissue Sculpter. The mild Initiator is pre-assembled for convenience and includes: the mild Trocar and Handle, mild Portal, mild Portal Grip, and mild Depth Guide. The mild Device Kit is utilized for tissue access, retraction, and resection within the lumbar spine via a minimally invasive posterior approach. The procedure is conducted percutaneously with the mild Tissue Sculpter and Bone Rongeur, placed through an introducer cannula, the mild Portal.
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    K Number
    K240535
    Device Name
    Digital ClarusScope System; Digital NeuroPEN System
    Manufacturer
    Clarus Medical, LLC
    Date Cleared
    2024-04-25

    (59 days)

    Product Code
    HRX, REG
    Regulation Number
    888.1100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digital ClarusScope System and Digital NeuroPEN System are intended for accessing and visualizing the spinal nerve roots, foramina, intervertebral disc, and surrounding tissues of the spine during discectomy procedures, bone and osteophyte removal, and procedures associated with ruptured or herniated discs.
    Device Description
    The Digital ClarusScope System and Digital NeuroPEN System are spinal endoscopes which provide a light source, camera, and HDMI output for visualization. Irrigation is provided for flushing during the procedure. The working channel facilitates the use of tools necessary for spinal procedures (Digital ClarusScope versions only). The Digital ClarusScope and Digital NeuroPEN are intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital ClarusScope and Digital NeuroPEN terminate in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a standard off-the-shelf HDMI video monitor which is not provided by Clarus and is not part of this 510(k) application; the other fitting is an irrigation extension tube with a female Luerlock connector.
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    K Number
    K233675
    Device Name
    FMS VUE™ Fluid Management and Tissue Debridement System
    Manufacturer
    DePuy Mitek, Inc.
    Date Cleared
    2024-02-26

    (102 days)

    Product Code
    HRX
    Regulation Number
    888.1100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FMS VUE™ Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.
    Device Description
    The FMS VUE Fluid Management and Tissue Debridement System is an arthroscopic pump system designed to provide optimal visibility of the surgical field by computer-controlled fluid regulation of intra-articular pressure, and flow during arthroscopic procedures. The system integrates a tissue debridement for controlled cutting, burring, shaving and abrading of bone and soft tissue. The FMS VUE Fluid Management and Tissue Debridement System consists of irrigation pump, which controls joint pressure, and the suction pump, which controls the flow of saline and waste from the joint. The FMS VUE Fluid Management and Tissue Debridement System includes an integrated shaver console, intended to provide controlled cutting, burring, shaving and abrading of bone and soft tissue. The FMS VUE Fluid Management and Tissue Debridement System is designed to work with the existing FMS VUE platform accessories including: foot pedal, remote hand control, shaver handpieces, FMS connect cable, tubing sets, blades, and burrs. The FMS VUE Fluid Management and Tissue Debridement System contains updates in the hardware, which include replaced near obsolescence components and new real panel connectors. The FMS VUE Fluid Management and Tissue Debridement System software modification includes an additional shaver oscillation profile algorithm.
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    K Number
    K233115
    Device Name
    Hawkeye Control Unit with Eyas Endoscope
    Manufacturer
    E Surgical, LLC
    Date Cleared
    2024-02-06

    (132 days)

    Product Code
    HRX
    Regulation Number
    888.1100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hawkeye Control Unit with Eyas Endoscope is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization and image capture of an interior body cavity through a surgical incision.
    Device Description
    The E Surgical Hawkeye Control Unit with Eyas Endoscope is an arthroscope system, consisting of the Hawkeye Control Unit (Medical Tablet plus Console Box), and the Eyas Endoscope. The Medical Tablet is a touch panel computer for the system function control, endoscope image displays and operation data storage. The Eyas Endoscope is a hand-held, single-use device for accessing the interior of a joint to capture the real-time image of the target site through a small incision. The Console Box is an interface between the Medical Tablet and Eyas Endoscope. There are 10 models of Eyas Endoscope in this system; including 2 different directions of view (0° and 30°) in combination with 5 different working lengths. All these models must be used in conjunction with Hawkeye Control Unit to perform as intended. The E Surgical Hawkeye Control Unit with Eyas Endoscope is also capable recording and storing the images in the system for later review.
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