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510(k) Data Aggregation

    K Number
    K250663
    Device Name
    Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
    Manufacturer
    Taewoong Medical Co., Ltd.
    Date Cleared
    2025-03-31

    (26 days)

    Product Code
    MUM, MQR
    Regulation Number
    878.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    Taewoong Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms. Niti-S Colonic Comfort Stent is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
    Device Description
    The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of an implantable metallic stent and an introducer system. The stent is made of nitinol wire and is designed as a flexible, fine mesh tubular prosthesis with several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm, while the Niti-S Colonic Comfort Stent is available in diameters of 22 mm and 24 mm. Both stent types are available in lengths of 60 mm, 80 mm, 100 mm, and 120 mm. The stent delivery system accommodates a 0.035 in (0.89 mm) guidewire. It is advanced over the guidewire and passed through an endoscope into the duodenum or colon. Fluoroscopy is recommended to ensure accurate device placement.
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    K Number
    K223067
    Device Name
    Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent
    Manufacturer
    Taewoong Medical Co., Ltd.
    Date Cleared
    2023-06-14

    (264 days)

    Product Code
    MUM
    Regulation Number
    878.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    Taewoong Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms. The Niti-S Colonic Comfort Stent is indicative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
    Device Description
    The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of the implantable metallic stent and introducer system. The stent is made of nitinol wire. It is a flexible, fine mesh tubular prosthesis that has several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm while the Niti-S Colonic Comfort Stent has diameters of 22 and 24 mm. They both have lengths of 60, 80, 100, and 120 mm. The introducer system accepts a 0.035 in (0.89 mm) guidewire. The introducer system is passed over the guidewire and through an endoscope into the duodenum or colon. Use of fluoroscopy is recommended to ensure correct placement of the device.
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    K Number
    K223256
    Device Name
    Optimos™ Cystotome
    Manufacturer
    Taewoong Medical Co., Ltd.
    Date Cleared
    2023-04-05

    (166 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Taewoong Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.
    Device Description
    Optimos™ Cystotome is an electrode which uses heat generated from the application of high frequency (HF) energy through the monopolar electrode to puncture a hole in tissue. Following a fine-needle aspiration (FNA) procedure, it is positioned over a guidewire, so the applied part is located at the area of interest. The Optimos™ Cystotome is for use to drain pancreatic pseudocysts. The Optimos™ Cystotome is a single use device provided sterile to the user. No reprocessing is performed by the user. The device is provided in three sizes, which have different diameters and tip lengths. The device itself consists of 3 parts: handle, sheath, and tip.
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    K Number
    K221482
    Device Name
    Esophageal TTS Stent
    Manufacturer
    Taewoong Medical Co., Ltd.
    Date Cleared
    2022-06-22

    (30 days)

    Product Code
    ESW
    Regulation Number
    878.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    Taewoong Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Esophageal TTS Stent is intended for use in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and occlusion of concurrent esophageal fistulas.
    Device Description
    The Esophageal TTS Stents consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the esophagus. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the esophagus to establish patency.
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