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510(k) Data Aggregation

    K Number
    K241734
    Device Name
    Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
    Date Cleared
    2025-03-05

    (261 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Well Lead Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Hydrophilic Intermittent Catheter is used to empty the bladder for patients with urinary retention or incomplete bladder emptying.
    Device Description
    Hydrophilic intermittent catheter is a sterile, single use hollow tube inserted into the bladder to drain the urine at regular intervals. The catheter also contains a Polyvinyl Pyrrolidone hydrophilic-coating and is sterilized by irradiation. The product can be used on patients who need intermittent urine drainage. The Hydrophilic intermittent catheter is available for use in professional medical facilities and home environments. The Hydrophilic Intermittent Catheter Ready to Use is placed in a wetting liquid, packed and sealed in a foil pouch and sterilized. The Hydrophilic Intermittent Catheter Compact is placed in a wetting liquid inside the container, which together with screw cap, connector and plug make up the primary packaging and the sterile barrier. The Hydrophilic Intermittent Catheter Ready to Use is available in three configurations: - Ready to use Female (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr) - Ready to use Standard (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr) - Ready to use Tiemann (10Fr, 12Fr, 14Fr, 16Fr, 18Fr) . The Hydrophilic Intermittent Catheter Compact is available in one configuration (8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 16Fr).
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    K Number
    K220722
    Device Name
    PVC Hydrophilic Urethral Catheter
    Date Cleared
    2023-05-22

    (434 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Well Lead Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization-CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the urethra for emptying the bladder.
    Device Description
    The device is a urethral catheter used for intermittent catheterization. The device is a flexible single use urinary catheter inserted through the urethra to drain the bladder. The device is a disposable polyvinyl chloride (PVC) catheter coated with a hydrophilic coating (polyacrylamide) and an optional water sachet is included, which can activate the lubricant coating on the PVC. The device is generally for use in professional medical facilities and home environments. The catheters come in sizes from 6Fr – 22Fr for the Male Model, 6Fr – 22Fr for the Female Model and 10Fr – 22Fr for the Tiemann Model. The catheter can connect to two different shapes of connector (called connector I and connector II) provided with the device. The connector enables the catheter to be connected to a urine bag or other collection apparatus. Urine can also be drained directly into the toilet. The catheter is intended to be used for less than 24 hours based on the biocompatibility information provided. It is expected that patients will use a new intermittent catheter multiple times a day (each time urine needs to be drained).
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    K Number
    K220036
    Device Name
    Wellead Ureteral Catheter
    Date Cleared
    2022-12-16

    (345 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Well Lead Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ureteral Catheter is used for temporary urine drainage, delivery of irrigation fluids, injection of contrast agent to the urinary tract, navigation of a tortuous ureter, access, advancement or exchange of wire guides (open-ended catheters only).
    Device Description
    Ureteral Catheters are single-use and sterile devices, which consist of catheter, adapter and guide wire. Ureteral Catheters are available in a variety of French sizes and distal tip configurations. Ureteral Catheters have 5 different distal tip configurations, which are closed round tip, open tapered tip, open tip, open soft tip and open cone tip. The adapter and guide wire are optional and the choice of Ureteral Catheter, adapter and guide wire should be based on the physician's preference and clinical situation. The catheter tube is made of Polyvinylchloride (PVC). The catheter is uncoated. Recommend duration of use: less than 24 hours.
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    K Number
    K211543
    Device Name
    Wei Nasal Jet Tube
    Date Cleared
    2022-07-21

    (428 days)

    Product Code
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    Well Lead Medical Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    WEI nasal jet tube is indication for airway management, inserted through nasal cavity. During and after insertion, the Jet Tube can supply jet ventilation intermittently. When the Jet tube is not in use, the main tube serves as the main oxygen supply channel, and oxygen is supplied through main tube. The PetCO2 Monitor tube can connect to CO2 monitoring machine to monitor CO2 status.
    Device Description
    Wei Nasal Jet Tube is a sterile, single-use nasopharyngeal airway management, monitor PetCO2 and mechanical ventilation. Wei Nasal Jet Tube inserted into a patient's pharynx through the nose, it provides active, pulsatile and powerful supraglottic jet oxygenation and ventilation (SJOV) via a jet channel built into the wall of its distal end. It can be used to monitor PetCO2 via another channel built into the wall and open to the middle lumen of the tube. Wei Nasal Jet Tube can also augment oxygen supplies for patients with respiratory suppression or apnea during difficult airway managements.
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    K Number
    K211814
    Device Name
    Wellead Endoscopic Seal
    Date Cleared
    2022-01-14

    (217 days)

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

    Well Lead Medical CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Endoscopic Seal is a self-sealing cap that is intended to prevent the backflow of fluid through the working channel of an endoscope.
    Device Description
    The Endoscopic Seal is mounted to the proximal port of the endoscope working channel and intended to resist the backflow of distention fluid when the channel is not being used or when instruments are passed through the working channel. The Endoscopic Seal consists of a silicone seal, an introducer, and an adapter with sealing ring (optional). The Introducer is used to enable improved access during endoscopic procedures. The Adapter and Sealing Ringare optional for Endoscopic Seal. They are used with the non-standard Luer endoscopes. The silicone seal combined with introducer can be used with all endoscopes with the proximal port of the working channel between 6 mm to 9 mm in its largest outside diameter. Mount the silicone seal onto the working channel of the Endoscope. Make sure the connection is tight. Insert the introducer into the silicone seal.If using the WOLF endoscope, mount the adapter with sealing ring onto the endoscope working channel port first and then place the silicone seal and introducer onto the adapter.
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    K Number
    K202134
    Device Name
    Well Lead All Silicone Foley Catheter with Temperature Sensor
    Date Cleared
    2021-04-08

    (251 days)

    Product Code
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Well Lead Medical Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    All Silicone Foley Catheter With Temperature Sensor is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical intervals.
    Device Description
    The All Silicone Foley Catheter with Temperature Sensor is made from medical grade silicone, consists of temperature sensor for monitoring core body temperature and Foley catheter including a shaft, drainage funnel, inflation funnel, balloon, valve, and X-ray opaque line. The device is provided sterile by ethylene oxide and is for single use only. It is provided in a variety of sizes and color-coded by size.
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    K Number
    K203119
    Device Name
    ClearPetra Suction-Evacuation Sheath
    Date Cleared
    2020-12-09

    (54 days)

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

    Well Lead Medical Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ClearPetra Suction-Evacuation Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during endoscopic procedures.
    Device Description
    The ClearPetra Suction-Evacuation Sheath consists of a straight distal tube and a proximal bifurcated tube. The distal straight tube of the ureteral access sheath is reinforced with metal wires for torque resistance. One segment of the proximal bifurcated tube is straight and is contiguous with the distal tube. The other is constructed in an oblique angle with a longitudinal pressure control vent. An obturator is included for the insertion of the sheath. The obturator can be locked to the proximal end of the straight tube using a luer lock mechanism. A rubber cap with central aperture is included as an accessory. It is to be placed at the proximal end of the straight tube after the removal of the obturator. The oblique tube is to be connected directly to a negative pressure aspirator with a clear tube or alternatively, connected to a specimen collector (packed separately) then onto a negative pressure aspirator.
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    K Number
    K182739
    Device Name
    Endotracheal Tube with Evacuation Lumen
    Date Cleared
    2019-12-11

    (439 days)

    Product Code
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELL LEAD MEDICAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Endotracheal Tube with Evacuation Lumen is intended for oral intubation and drainage of the subglottic space for airway management.
    Device Description
    The Endotracheal Tube with Evacuation Lumen is sterile, single-use devices supplied with a standard 15mm connector. The Endotracheal Tube with Evacuation Lumen is a Magill curved construction with primary lumen for patient ventilation. Two (2) narrower lumens within the primary wall are used for cuff inflation and subglottic evacuation (vacuum). A low pressure, conformable cuff is inflated through the inflation tube with pilot balloon using a standard syringe (air only) through a non-return valve. For evacuation of subglottic secretions, a separate suction line, with a capped connector, connects to standard hospital vacuum receptacles. The tube incorporates a radiopaque line to assist in radiographic visualization. The Endotracheal Tube with Evacuation Lumen is PVC (polyvinylchloride) tube with a cylindrical-shaped cuff. The cuff is available with two materials PVC (polyvinylchloride) and PU(polyurethane). It is available in sizes 6.0, 6.5, 7.0, 7.5, 8.0, 8.5 and 9.0mm and consists of tube, cuff, inflation tube, non-return valve, pilot balloon, 15mm connector, suction line.
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    K Number
    K162340
    Device Name
    Stomach Tube
    Date Cleared
    2017-10-11

    (415 days)

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

    WELL LEAD MEDICAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The device is available in sizes 6Fr to 22Fr for use in adults only.
    Device Description
    The Stomach Tube is a sterile, single-use tube manufactured in various sizes from medical grade PVC. The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The tube is inserted into a patient's stomach through the patient's nose or mouth. The Stomach Tube is supplied in French size ranging from 6 to 22, consists of main tube and connector. The stomach tube connector connects to suction device for suctioning, The tube is available in open tip and closed tip form. It is composed of biologically safe materials and supplied sterile and intended for single use only.
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    K Number
    K160801
    Device Name
    Well Lead Extraction Bag
    Date Cleared
    2016-11-29

    (251 days)

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

    WELL LEAD MEDICAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Well Lead Extraction Bag is intended for use by qualified surgeons in tissue extraction procedures during laparoscopic surgery.
    Device Description
    The Well Lead Extraction Bag is used for removal of tissue specimens during a suitable laparoscopic surgery.The device consists of a cylindrical sheath, a pusher and a polyurethane bag that minimizes spillage and intraoperative contamination by isolating and containing specimens. The bag is made of biocompatible high strength PU material, it is transparent and soft. which makes a qood visuality. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only. It's easy to enter, open, close and exit, higher efficiency, and different type and size available. It is offerd in 4 types: Type B, Type C, Type D and range in bag volume from 200ml for different surgery needs. The well thought-out rang of types and sizes are suitable for all laparoscopic procedures. The main differences between all types are the deployment system and operation method.
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