FDA Approves Olympus’ Biopsy Needle

The FDA gave 510(k) clearance to Olympus’ EZ Shot Plus 25 G needle, used for collecting tissue samples in the gastrointestinal tract.

The new 25 G model is designed to be used with an Olympus endoscopic ultrasound system for guided fine needle aspiration and fine needle biopsy of lesions within the gastrointestinal tract, such as lymph nodes and perirectal masses.

The indication for fine needle biopsy may provide faster pathological diagnosis of tissue collected during surgery.