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510(k) Data Aggregation

    K Number
    K231822
    Device Name
    GOLFF Sterile Anti-Fog Solution
    Manufacturer
    Batrik Medical Manufacturing Inc.
    Date Cleared
    2024-02-26

    (250 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GOLFF Sterile Anti-Fog Solution is a single-use, medical device, anti-fog solution used by hospital staff to apply on lenses of endoscopic and laparoscopic cameras. The solution is provided in an easy-to-squeeze bottle and comes with an adhesive-backed sponge for secure placement.
    Device Description
    GOLFF Sterile Anti-Fog Solution is used to prevent fogging on endoscopic lenses. It ensures clearer vision and avoids unnecessary interruptions during surgery. It also comes with an adhesive-backed sponge, for secure placement, which is also radio-opaque and not made with natural rubber latex. The product is available under reference code GOLFF-R1.
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    K Number
    K221293
    Device Name
    E-Brik Visualization Assistant
    Manufacturer
    JDI Surgical, Inc.
    Date Cleared
    2022-07-07

    (64 days)

    Product Code
    OCT, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The E-Brik™ Visualization Assistant is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
    Device Description
    The E-Brik™ Visualization Assistant is designed as an accessory to be used prior to and during procedures that utilize a laparoscope or endoscope. It is designed to warm the scope above body temperature and apply a warmed surfactant. The device is provided sterile and is intended for single use only in a healthcare facility/ hospital. The E-Brik™ is activated by the user removing the nonconductive slip sheet from the bottom, completing the battery circuit. Once activated, internal circuitry begins the warming function of the device. The user is alerted to this activation by an LED which is illuminated below both ports. The E-Brik™ has two ports that accept endoscopes and/or laparoscopes ranging from 3mm to 10mm in diameter. Both ports can be used prior to the surgical case to warm the scope(s) before the insertion into a body cavity. The E-Brik™ can act as a scope stand as it is designed to support the main axis of the scope, allowing it to rest horizontally on a flat stable surface. A sterile surfactant solution is added to the ports prior to use, which is warmed when the device is active. The ports allow for the user to apply the warmed surfactant prior to and during the case. The E-Brik™ is powered by alkaline batteries and has a single-use surgical life of a minimum of 4 hours.
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    K Number
    K190864
    Device Name
    Konix Anti-Fog Solution
    Manufacturer
    Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler
    Date Cleared
    2020-08-27

    (512 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KONIX Anti-Fog solution is a sterile, disposable, functional, anti-fog solution. The antifog solution is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. KONIX Antifog Solution is used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures.
    Device Description
    Konix Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is released to the market as sterile and disposable with one polyurethane foam pad in a 6 ml polyethylene bottle. Secondary packaging is composed of PET film and Medical Kraft Sealing Paper. Konix Anti-Fog Solution is intended to be used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures. The mechanism of defogging or anti-fogging action of Konix Anti-Fog Solution, works by physically changing the water droplets that form on the lens surface from round droplets, to a flat transparent sheet of water, a phenomenon known as 'wetting'.
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    K Number
    K181887
    Device Name
    AMD Anti-Fog Solution
    Manufacturer
    Advanced Medical Design Co., Ltd
    Date Cleared
    2019-01-22

    (193 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AMD Anti-Fog Solution is a sterile and single-use laparoscopic accessory device for use prior to and during endoscopic and laparoscopic procedures. The product is intended to prevent condensation of the distal lenses of the endoscopic/ laparoscopic instruments during the surgery. The product is intended for prescription use only.
    Device Description
    The AMD Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is packaged by the Tyvek" Pouch which includes one clear plastic screw top dispenser bottle with the volume of 6 mL and one polyurethane (PU) foam pad with x-ray detectable radiopaque ribbon. The solution is a clear/colorless, odorless, and aqueous solution which comprises of surfactant (≤2%), isopropyl alcohol (≤2%), and water (≥96%). The polyurethane (PU) foam pad is an adhesivebacked sponge with radiopaque ribbon that can be used to introduce the solution into the surface of the lenses.
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    K Number
    K163257
    Device Name
    VitreOx Anti-fog Solution
    Manufacturer
    SiO2 Nanotech, LLC
    Date Cleared
    2017-05-24

    (191 days)

    Product Code
    OCT, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitreOx® is a temporary anti-fog coating and therein defogs devices such as a laparoscopic accessory intended to facilitate intraoperative defogging of the laparoscope lens thereby maintaining visualization of the surgical site.
    Device Description
    The device, VitreOx®, is a biocompatible, aqueous solution, when used as indicated. In addition, the solution is alcohol-free. It functions in the same manner as the predicate device. The device is intended to be used prior and during minimal invasive surgeries, to prevent fogging of the lens of devices (laparoscope) that provide visualization during the procedure. The device accessory VitreOx®, can be removed from the lens with typical surgical cleaning methods such as scrubbing with soap and water, autoclaving, etc. It is a sterile, single-use, disposable, long-lasting (beyond average surgery time of 90 minutes) anti-fog solution that can be applied on endoscope and laparoscope lenses, as well as endoscope sheaths. It is effective instantaneously, wet; but is even more lasting if allowed to dry, or applied prior to surgery to lenses.
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    K Number
    K152948
    Device Name
    Medline Anti-Fog Solution
    Manufacturer
    Medline Industries, Inc.
    Date Cleared
    2016-02-04

    (121 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The anti-fog solution is intended to be used to prevent 'fogging'' (caused by condensation) on the lenses of endoscopic/ laparoscopic instruments which are likely to fog during use.
    Device Description
    Not Found
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    K Number
    K120821
    Device Name
    LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM
    Manufacturer
    MISDER, LLC
    Date Cleared
    2012-05-11

    (53 days)

    Product Code
    OCT, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LLICS™ is indicated for use in laparoscopic surgeries to clean the laparoscope lens within the surgical cavity, preventing temperature changes associated with lens fogging.
    Device Description
    The LLICS sterile system is intended for single-procedure use. Each LLICS package includes two cleaning swabs that can be introduced through an existing surgical trocar or cannula and one bottle of surfactant. Each cleaning swab consists of a foam tip mounted on a plastic rod, an outer cannula, and an actuator handle. The surfactant is applied to the foam tip on the cleaning swab. The tip is then retracted into the LLICS cannula before it is introduced through the surgical trocar/cannula. The LLICS cannula helps to keep the foam tip clean while it passes through the existing surgical trocar/cannula. Once the LLICS device has passed through the surgical trocar/cannula, the surgeon visualizes the end of the LLICS cannula and uses the actuator handle to deploy the surfactant-moistened foam tip. The actuator handle remains outside the body and can be operated with one hand. The surgeon uses the foam tip to clean the endoscope lens and then retracts the tip into the LLICS cannula. The retracted device can be left in the surgical trocar/cannula for additional cleaning cycles or removed to make the trocar/cannula available for introducing other endoscope accessories.
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    K Number
    K111622
    Device Name
    UNIMAX ANTI-FOG SOLUTION
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Date Cleared
    2011-09-09

    (91 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Unimax Anti-Fog Solution is intended to be used to prevent "fogging" (caused by condensation) on the lenses of endoscopic/laparoscopic instruments which are likely to fog during use.
    Device Description
    The Unimax Anti-Fog Solution is a clear / colorless, water soluble solution. The model with alcohol is comprised of DPGMME (=2%), Isopropyl alcohol (=6%), and Deionized water (=92%), while the model without alcohol is comprised of DPGMME (=2%) and Deionized water (=98%). Unimax Anti-Fog Solution functions by reducing the surface tension of water, thus preventing water droplets (fog) from forming on the lenses of endoscopic / laparoscopic instruments during use. This solution is bottled in a volume of 6cc's in a 10cc clear plastic dropper bottle. Included in the tyvek pouch packaging of this product is a 4.5*4.5*0.5 (L*W*H) adhesive backed, non-abrasive, x-ray detectable radiopaque/nonradiopaque, polyurethane foam pad for applying the product to endoscopic / laparoscopic lenses. This product is sold sterile to healthcare professionals only.
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    K Number
    K102452
    Device Name
    DEFOGGING AND CLEANING SOLUTION- FLO-X
    Manufacturer
    MINIMALLY INVASIVE DEVICES LLC
    Date Cleared
    2010-12-23

    (118 days)

    Product Code
    OCT
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the laparoscope lens thereby maintaining visualization of the surgical site.
    Device Description
    The Minimally Invasive Defogging and Cleaning Solution is a biocompatible surfactant (Docusate Sodium) when used as indicated. It functions in the same manner as the predicate devices. It is intended to be used to prevent fogging of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries. Additionally, the solution can be used to clean the end of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries (i.e. to rinse lens intra-operatively by rinsing any debris from the lens which becomes attached to the lens as a result of the procedure.)
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    K Number
    K080613
    Device Name
    CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045
    Manufacturer
    MINIMALLY INVASIVE DEVICES LLC
    Date Cleared
    2008-11-06

    (247 days)

    Product Code
    OCT, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clear-Vu System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site.
    Device Description
    The Clear-Vu System consists of a multi-lumen sheath assembly mounted on the shaft of the laparoscope, which connects to the existing CO₂ insufflation circuit to defog the laparoscope lens and divert surgical debris, and connects to the existing surgical irrigation system to clean the lens via saline flush.
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