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510(k) Data Aggregation

    K Number
    K242586
    Device Name
    ArgoCap (200.52)
    Manufacturer
    Ovesco Endoscopy AG
    Date Cleared
    2025-05-22

    (265 days)

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

    OCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ArgoCap has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy. The ArgoCap is intended for the following: - Gastrointestinal endoscopic mucosal resection and coagulation - Keeping the suitable depth of the endoscope's view field
    Device Description
    Not Found
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    K Number
    K241704
    Device Name
    Endoscopic Water Pump
    Manufacturer
    Hangzhou AGS MedTech Co., Ltd.
    Date Cleared
    2025-03-20

    (280 days)

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

    OCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Water Pump is a peristaltic pump intended to supply fluid to compatible endoscopes or endotherapy devices for irrigation of the gastric and colonic mucosa during endoscopic or endotherapeutic procedures, allowing to aid in visualisation, diagnosis and treatment.
    Device Description
    AGS's Endoscopic Water Pump comprises: - A host machine (including drive system, peristaltic pump head, housing, etc.); - - Operating component (Rotatable Knob and Footswitch); - - -Hanger assembly(optional); - -An irrigation tube (optional) The Endoscopic Water Pump is a motorized pump designed to transfer water from a bottle, via a tube, to an endoscope or EndoTherapy devices, and the pump is operated by a footswitch. It uses a peristaltic pump head to move the water through the tube. The speed of the rotation of the pump head is adjustable by the user, using flow control knob on the front of the pump.
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    K Number
    K242357
    Device Name
    Water Container (MAJ-901); Water Container (MAJ-902)
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2024-10-07

    (60 days)

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

    OCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The water container MAJ-901 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope. Do not use this instrument for any purpose other than its intended use. The water container MAJ-902 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope. Do not use this instrument for any purpose other than its intended use.
    Device Description
    The MAJ-901 and MAJ-902 have been designed to be used with Olympus light sources and endoscopes to allow gas insufflation and water feeding from the endoscope. MAJ-901 and MAJ-902 are both comprised of a Lid, Container, O-ring, and Container Protector. Other than Lid, the devices are the same. MAJ-902 also includes a "gas tube connector" in the lid for carbon dioxide gas delivery. Additionally, MAJ-902 includes a Caution tag that the MAJ-901 does not.
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    K Number
    K241874
    Device Name
    Aspiration Catheter (2189)
    Manufacturer
    Hobbs Medical, Inc.
    Date Cleared
    2024-09-24

    (88 days)

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

    OCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be utilized by a trained physician through a flexible endoscope for the collection of duodenal or jejunal fluids for diagnostic analysis.
    Device Description
    The Hobbs Medical Aspiration Catheter is a sheath within a sheath design. The inner sheath is actuated using a proximal handle. The inner sheath is protected by an elastomeric membrane that has a slit at the distal end to allow for the inner sheath to advance. The inner sheath has three side holes at the distal tip for collection of aspirate. Once the sample is collected the inner sheath is retracted to protect the sample from contamination as it is withdrawn from the endoscope.
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    K Number
    K242134
    Device Name
    ClearCap Distal Attachment
    Manufacturer
    FINEMEDIX Co., Ltd.
    Date Cleared
    2024-08-20

    (29 days)

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

    OCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearCap Distal Attachment has been designed to the distal end of the endoscope to facilitate endoscopic therapy. The ClearCap Distal Attachment is intended for the following: - · Gastrointestinal mucosal resection (endoscopic mucosal resection) - · Keeping the suitable depth of the endoscope's view field
    Device Description
    The ClearCap Distal Attachment is a sterile distal attachment intended to improve endoscopic control and to help maintain the clear view by keeping a moderate distance from the tissues during endoscopic surgical procedures. The ClearCap Distal Attachment is comprised of three main sections: an attaching portion, a distal portion and draining holes. The attaching portion is connecting portion of the attachment to an applicable endoscope; a distal portion is the ending portion of the attachment and the 2 draining holes on the sidewall are to discharge bleeding and some foreign matter. Applicable lesions are both lower digestive tract (=gastrointestinal (GI) tract) and upper GI tract. The model name FM-CC01, FM-CC05, FM-CC06 and FM-CC07 are for lower GI Tract, and FM-CC02, FM-CC03 and FM-CC04 are for upper GI tract. It is available in various sizes of diameter to assure the compatibility of various endoscope outer diameters. The average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or resterilized.
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    K Number
    K233442
    Device Name
    troCarWash™ System
    Manufacturer
    Biotex, Inc.
    Date Cleared
    2024-05-21

    (216 days)

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

    OCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The troCarWash™ system consists of a reusable control unit and a disposable, sterile, single-use trocar intended to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintain a clear image of the surgical site.
    Device Description
    The troCarWash™ system is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the distal lens of the laparoscope. Consisting of a mains powered reusable control unit, and a single use disposable trocar, obturator, and tubing set, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat, and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures providing a clear image of the surgical site. The disposable portion of the system is sterilized via irradiation and has limited (<24 hours) patient contact with abdominal tissue. The trocar and obturator are primarily made of ABS and polycarbonate, and the tubing set is made of ABS, Polycarbonate, and PVC tubing. The system is intended for use in typical hospital environments by medical professionals and is suitable for all patients approved for laparoscopic operations. The system incorporates a software that initiates a short (<250 millisecond) wash and dry mechanism to efficiently clean the lens of the laparoscope and may be initiated with a natural single-handed surgical motion of retracting the scope momentarily into the supplied trocar.
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    K Number
    K230773
    Device Name
    Endoscopy Irrigation Tubing
    Manufacturer
    Zhejiang Chuangxiang Medical Technology Co., LTD.
    Date Cleared
    2023-11-21

    (245 days)

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

    OCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 24 hour use Endoscopy Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
    Device Description
    The Endoscopy Irrigation Tubing is intended for 24-hour use and then discarded. The endoscopy irrigation tubing is manufactured for use in conjunction with sterile water bottle, and together with irrigation pumps. The endoscopy irrigation tubing is individually packed in sealed package, sold as a sterile device. The endoscopy irrigation tubing is designed to be attached to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.
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    K Number
    K231471
    Device Name
    Air/Water Bottle Tubing, CO2 Source Tubing
    Manufacturer
    Zhejiang Chuangxiang Medical Technology Co., LTD.
    Date Cleared
    2023-09-08

    (109 days)

    Product Code
    OCX, FAJ, FCX
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Air/Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device. The CO2 Source Tubing is intended to be used with a carbon dioxide (CO2) source with the purpose of supplying CO2 to the endoscope during endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.
    Device Description
    The proposed device includes two (2) categories: - Air/Water Bottle Tubing - CO2 Source Tubing The Air/Water Bottle Tubing and CO2 Source Tubing are intended for 24-hour multi-patient use. Air/water bottle tubing is supplied in sterile and CO₂ Source Tubing is supplied in non-sterile. 6.1 The Air/Water Bottle Tubing The Air/Water Bottle Tubing is manufactured for use in conjunction with a sterile water bottle, and together with OLYMPUS®140/240, 160/260, 180/280, 190/290 series endoscopes. The Air/Water Bottle Tubing is individually packed in sealed package, sold as a sterile device. The Air/Water Bottle Tubing is designed to be attached to the air/water port of the endoscopes to provide irrigation through the air/water channel to the distal end of endoscope. There are two types of the device Air/Water Bottle Tubing provided by the manufacturer, such as type A and type B. Type B has an additional air extended tubing but type A does not. The clinician selects the appropriate model according to the actual clinical needs. 6.2 The CO2 Source Tubing The CO2 Source Tubing is manufactured for use in conjunction with air/water bottle tubing and CO2 insufflator. The CO2 Source tubing is individually packed in a sealed package, and sold as a non-sterile device. The CO2 Source Tubing is designed to be attached to the air/water bottle tubing and the outlet of the CO2 insufflator to provide irrigation and CO2 insufflation through the air/water channel to the distal end of endoscope.
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    K Number
    K231418
    Device Name
    ENDOGATOR™ Hybrid Irrigation Tubing
    Manufacturer
    Medivators
    Date Cleared
    2023-08-14

    (90 days)

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

    OCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENDOGATOR™ Hybrid Irrigation Tubing (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump) or CO2 (via a CO2 supply) along with sterile water during GI endoscopic procedures when used in conjunction with an irrigation pump or cautery unit.
    Device Description
    The ENDOGATOR™ HYBRID Irrigation Tubing device contains a threaded cap and tubeset designed to be attached to sterile water bottles. The proximal end of the irrigation tubing includes the threaded bottle cap for attachment to a sterile water bottle. The bottle cap has three tubes attached, one for receiving CO2 (and air in the case of Pentax SKU's), one coaxial tube which has an inner lens rinsing uptake tube surrounded by an air/CO2 delivery tube, and one for delivering water for irrigation which interfaces with an irrigation pump. The water delivery tubes, both irrigation as well as lens rinsing include backflow check valves.
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    K Number
    K231602
    Device Name
    Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
    Manufacturer
    GA Health Company Limited
    Date Cleared
    2023-08-01

    (61 days)

    Product Code
    OCX, K19, PRO, SEC
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Protego Air Water Connector: The single use Protego Air Water Connector is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. Protego Air Water Bottle Tubing: Protego Air Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device. Protego Hybrid Tubing: Protego Hybrid Tubing is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2, water and irrigation during endoscopic procedures in conjunction with an irrigation pump. It is a 24-hour multi-patient use device.
    Device Description
    The Protego Air Water Connector is intended for single use then discarded. The Protego Air Water Bottle Tubing and Protego Hybrid Tubing are intended for 24-hour use then discarded. All Protego Air Water Connector, Protego Air Water Bottle Tubing and Protego Hybrid Tubing are provided sterile. The Air Water Connector is used in conjunction with air water bottle tubing or hybrid tubing, intended to supply air/CO2 and water during gastro-intestinal endoscopic procedure. It is connected to the air/water port of the endoscope to provide connection from the air/water bottle tubing to the endoscope. The Air Water Bottle Tubing is connected to the air/water port of the endoscope and the sterile water bottle to supply air/ CO2 or sterile water during the GI endoscopic procedure. The Hybrid Tubing is composed of air/water bottle tubing and irrigation tubing, which is intended to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastro-intestinal endoscopic procedure.
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