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510(k) Data Aggregation

    K Number
    K242901
    Device Name
    ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
    Manufacturer
    Tools for Surgery, LLC
    Date Cleared
    2025-01-10

    (109 days)

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

    Tools for Surgery, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ZZIREN™ Orogastric Tube is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, to serve as a size guide, and to test for leaks.
    Device Description
    The ZZIREN™ Orogastric Tube is a non-sterile, single use device comprising a 37-inch-long insertion tube, a Y extension containing a suction regulating valve, and a pinch clamp. An accessory straight connector is included. The insertion is made of flexible polyvinylchloride (PVC). The suction requlating valve limits negative pressure applied to the stomach or intestine to less than 175 mmHg, produces an audible signal when the suction pressure exceeds ~160 mmHg, and is identical in all models. All six models have multiple apertures in proximity to a rounded distal tip. Three of the models, ZZ-SGT-36, ZZ-SGT-40 have side-holes extending 13 cm from the tip, and three models, ZZ-GBT-36, and ZZ-GBT-40, have side-holes extending 6 cm from the tip. The insertion tubes have diameters of 32, 36, and 40 Fr and humeric markings to indicate depth of insertion.
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    K Number
    K220218
    Device Name
    Siren SGT
    Manufacturer
    Tools for Surgery, LLC
    Date Cleared
    2022-05-18

    (112 days)

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

    Tools for Surgery, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SIREN SGT™ is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, and to assist in gastric sleeve formation by decompressing and stabilizing the stomach, and by serving as a sizing guide.
    Device Description
    The Tools for Surgery™ SIREN SGT™ gastric tube is a clean, non-sterile, single patient use device, comprising a 36 Fr insertion tube portion 109 cm long, a hub containing a suction regulating valve, an extension tube, pinch clamp, and connector. Tubular portions including the hub are flexible polyvinylchloride (PVC). There are multiple apertures in proximity to a rounded distal tip. Line and numeric markings are provided to indicate depth of insertion. The suction regulating valve limits negative pressure applied to the stomach to less than 175 mmHg, and produces an audible signal when the suction pressure in the stomach exceeds ≈160 mmHg.
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    K Number
    K040109
    Device Name
    HEMORRHAGE OCCLUDER PIN
    Manufacturer
    TOOLS FOR SURGERY, LLC
    Date Cleared
    2004-03-25

    (65 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOOLS FOR SURGERY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemorrhage Occluder Pin is indicated for the control of localized severe presacral hemorrhage during pelvic surgery. When other techniques (cautery, suture, clamping, etc.) are judged ineffective.
    Device Description
    The Hemorrhage Occluder Pin is a 7 mm long pin capped with an 8 mm diameter, 1.5 mm thick truncated conc-shaped head. The 1.25 mm diameter pin section has four tissue and bone retaining ridges formed by machining four equally spaced truncated conical sections. It is made of medical grade titanium suitable for implantation.
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    K Number
    K040110
    Device Name
    EASY LOOP, MODEL EZL-01
    Manufacturer
    TOOLS FOR SURGERY, LLC
    Date Cleared
    2004-03-24

    (64 days)

    Product Code
    EZP
    Regulation Number
    876.4270
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOOLS FOR SURGERY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Easy Loop is indicated for use in abdominal surgical procedures generally referred the Lady Loop is mare specifically referred to as loop ileostomy and loop colostomy, where a loop of bowel is pulled through an abdominal incision and retained colosiony, which a loop of bonet to pair in paints the exteriorized loop of bowel from retracting back into the abdominal cavity, is used in conjunction with commercially available ostomy appliances which collect the evacuated feces.
    Device Description
    The Easy Loop is constructed of an eight inch long x 0.28" diameter PVC flexible tubing, to which is bonded at each end a 1.45" long generally arrowshaped slotted PVC coupling member whose shape allows easy passage through the mesentery for placement of the device while resisting unintended withdrawal , and whose shape and slots permit interlocking of the two ends of the device to form a closed loop around the exteriorized loop of bowel.
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