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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.

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.

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.

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The MD Tech Biopsy-Set is intended for the purpose of harvesting bone and/or bone marrow specimens.

Our company is presently authorized by the Food and Drug Administration to manufacture soft tissue biopsy needles, K944837 The bone biopsy needle is a variation of this needle.

The MD Tech Biopsy-Set Bone and Bone marrow is 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.

The provided text does not contain information about acceptance criteria, device performance metrics, or any study details that would allow for the completion of the requested table and subsequent questions. The document is a 510(k) summary for a bone and bone marrow biopsy needle, focusing on substantial equivalence to predicate devices and a description of the device's intended use and mechanism. It does not include data from performance studies.

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