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# Praxis 510(k) for Biopsy Device Cleared
- URL: https://www.fdaweb.com/praxis-510-k-for-biopsy-device-cleared/
- Published: 2023-10-17T12:00:00.000Z
- Updated: 2026-09-14T14:13:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155576

FDA has cleared a Praxis Medical 510(k) for its EndoCore EBUS-TBNA fine needle biopsy device. “Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) is used for the diagnosis and staging of lung cancer,” the company says. “This procedure is performed by inserting a long, flexible fine needle through a bronchoscope for biopsy and pathological analysis. The cellular material collected can be viewed under a microscope to determine if a mass is malignant and identify tumor-specific mutations to guide treatment.”

The device is designed to “enhance” the outcomes of this procedure, according to Praxis, adding that it is powered by a motor that rotates the needle during biopsy to help “cellular harvesting.” “This unique rotary motion enables the needle to shear off large tissue samples that can help physicians make a comprehensive diagnosis,” it adds.