FDA Product Code KNW: Instrument, Biopsy

Tissue biopsy is the definitive diagnostic procedure in oncology and pathology. FDA product code KNW covers biopsy instruments used to obtain tissue samples for histopathological analysis.

These devices use needle-based, vacuum-assisted, or mechanical cutting mechanisms to remove representative tissue cores from suspect lesions. They are used across specialties including breast surgery, urology, gastroenterology, and interventional radiology.

KNW devices are Class II medical devices, regulated under 21 CFR 876.1075 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Medical Device Technologies, Inc., C.R. Bard, Inc. and Gallini U.S., LLC.