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The ZeniCore™ Automatic Biopsy Instrument and optional Co-Axial Introducer Needle is a single-use device indicated for obtaining core samples of soft tissue masses via percutaneous needle biopsy. It is not intended for use in bone.

The ZeniCore™ Automatic Biopsy Instrument and optional, coaxial Introducer needle is a single-use medical device intended for obtaining core soft tissue samples via percutaneous needle biopsy. It is not intended for use in bone lesions. The ZeniCore™ Automatic Biopsy Instrument is a sterile, single patient use device comprised of a spring-loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection than can be used with an optional corresponding coaxial Introducer Needle. The position of the needle may be visualized by imaging techniques such as X-ray, fluoroscopy, and ultrasound. The needle has an echogenic tip with numerically ordered centimeter markings to facilitate precise depth placement. The throw length of the needle when collecting a specimen is 25mm. There are five available needle gauge (G) sizes (12G, 14G, 16G, 18G and 20G) which are identified by a color-coded actuator button. The device is sold either standalone, or as a kit, with an optional, corresponding coaxial needle (cleared under K980004).

The optional Co-Axial Introducer Needle system includes an outer cannula and an inner stylet which terminate in a trocar tip and serves to support acquisition of tissue samples. Each Co-Axial Introducer Needle has an adjustable spring clip that serves as a locking mechanism to secure the position of the outer co-axial needle relative to the skin which ensures the biopsy needle does not accidentally slide forward or backward during the procedure, thereby maintaining the accuracy and safety of the biopsy. The Luer cap of the stylet is color coded to match the corresponding biopsy instrument it is sized to fit.

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