ClearTip FNA and FNB Types

The ClearTip FNA and FNB Types is a manually operated endoscopic biopsy needle instrument designed to obtain tissue specimens from the gastrointestinal tract. It is intended for ultrasonically guided fine needle aspiration of submucosal and extraluminal lesions, such as lymph nodes and abnormal mediastinal tissue, and is supplied sterile for single-patient use only.

The device features adjustable needle gauges (19, 22, 25G), needle lengths up to 8 cm with 0-5 cm adjustment range, and a stainless steel sheath with PEEK/PTFE material options. It includes a stylet, uses a syringe and stopcock for aspiration, has a 3-year shelf life, and is sterilized via ethylene oxide. Key differences from predicates include expanded needle gauge options, increased sheath length (1,510 mm), and modified sheath material composition.

Not stated in this summary.

The subject device shares the same indications for use, regulatory classification (Class II biopsy instrument), principle of manual aspiration operation, and fundamental design characteristics as the predicate devices. While the device differs in needle gauge options, needle length, adjustment ranges, and sheath material, the manufacturer demonstrated through biocompatibility and performance testing (including sterilization validation, dimensions, operability, bending strength, tensile force, and endoscope compatibility) that these differences do not raise safety or effectiveness concerns. The expanded specifications still encompass and remain compatible with the predicate device functionality.