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510(k) Data Aggregation

    K Number
    K980196
    Device Name
    MD TECH BIOPSY SET FOR BONE AND BONE MARROW
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    1998-02-03

    (14 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K961959,K890925,K902177,K962001
    Predicate For
    K043523,K051506,K062833,K162588,K180807
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Manan™ Biopsy Set for Bone and Bone Marrow is intended for the purpose of harvesting bone and/or bone marrow specimens. They are inserted percutaneously, adjacent to the biopsy site. Access to the bone and/or bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone and/or bone marrow specimen(s) is accomplished both by mechanical and negative pressure (aspiration) which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.

    In addition to the above, the pediatic bone marrow needle is intended for the purpose of obtaining access into medullary cavities for the purposes of initiating resuscitative infusion or for aspirating marrow in pediatic patients.

    Device Description

    These devices are intended for the purpose of harvesting bone marrow specimens. They are inserted percutaneously, adjacent to the biopsy site. Access to the bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone marrow speciment(s) is accomplished both by mechanical and negative pressure (aspiration) which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.

    In addition to the above, the pediatric bone marrow needle is intended for the purpose of obtaining access into medullary cavities for the purposes of initiative infusion or for aspirating marrow in pediatric patients.

    AI/ML Overview

    This document is a 510(k) summary for the Manan™ Biopsy Set for Bone and Bone Marrow, and a clearance letter from the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against predefined acceptance criteria.

    Therefore, I cannot provide the requested information based on the input provided.

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