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510(k) Data Aggregation

    K Number
    K231117
    Device Name
    neXus Ultrasonic Surgical Aspirator System
    Manufacturer
    Misonix, LLC, a Bioventus Company
    Date Cleared
    2023-06-23

    (64 days)

    Product Code
    LFL, GEI
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Misonix, LLC, a Bioventus Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Misonix Inc. neXus® Ultrasonic System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue. The indications for use for the Standard Handpiece in combination with BoneScalpel® and SonicOne® OR probe kit accessory configurations, the SonaStar® Long and Short handpieces in combination with SonaStar® probe kit accessory configurations, the BoneScalpel Access® handpiece with BoneScalpel Access® probe kit accessory configurations, and the SonaStar Elite Handpiece with probe kit accessory configurations are listed below. Standard Handpiece with BoneScalpel Probe Kit Indicated for use in the fragmentation, emulsification of soft and hard (e.g., bone) tissue in the following surgical specialties: - · Neurosurgery - · Gastrointestinal and Affiliated Organ Surgery - · Urological Surgery - · Plastic and Reconstructive Surgery - · General Surgery - · Orthopedic Surgery - · Gynecology External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids. - · Thoracic Surgery Limited pulmonary resection such as segmentectomical subsegmentectomies and metastatectomies. · Wound Care The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. Standard Handpiece with SonicOne Probe Kits Indicated for use in the fragmentation and aspiration of soft and hard tissue (i.e. bone) in the following surgical specialty: · Wound Care The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. · Plastic and Reconstructive Surgery neXus SonaStar Handpieces with SonaStar Probe Kits Indicated for use in the fragmentation and aspiration of both soft and hard (i.e., bone) tissue in the following surgical specialties: · Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy · Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy - · Plastic and Reconstructive Surgery · General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures - · Orthopedic Surgery - · Gynecological Surgery except as contraindicated for uterine fibroids. - · Thoracic Surgery · Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy · Thoracoscopic Surgery The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components. Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kits Indicated for use in the fragmentation of soft and hard (e.g., bone) tissue in the following surgical specialties: - · Neurosurgery - · Gastrointestinal and Affiliated Organ Surgery - · Urological Surgery - · Plastic and Reconstructive Surgery - · General Surgery - Orthopedic Surgery - · Gynecology External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adentis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids. · Thoracic Surgery Limited pulmonary resection such as segmentectomical subsegmentectomies and metastatectomies. SonaStar Elite Handpiece with SonaStar Elite Probe Kits Indicated for use in the fragmentation of soft and hard (e.g., bone) tissue in the following surgical specialties: - · Neurosurgery · Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy - · Urological Surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy - · Plastic and Reconstructive Surgery · General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures - Orthopedic Surgery - · Gynecological Surgery except as contraindicated for uterine fibroids. - · Thoracic Surgery · Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy · Thoracoscopic Surgery The system may also be combined with electrosurgery using optional RF surgery interface components.
    Device Description
    The neXus Ultrasonic Surgical Aspirator System is intended for fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue. The system includes a generator housed inside the console. A reusable handpiece is plugged directly into the front panel of the console. The generator and handpiece are compatible with various single use disposable "probes" which are selected and attached to the handpiece by the end user. An irrigation system provides sterile irrigant to the operative site. An aspiration system removes the fragmented, emulsified material and waste liquids from the operative site. Accessories include a wireless footswitch, various probe tip combinations, sterilization trays, probe covers, assembly & disassembly wrenches, irrigation tubing sets, disposable electrocautery cable, and waste collection canisters.
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