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 Senorx, Inc., Promisemed Hangzhou Meditech Co., Ltd. and SurGenTec, LLC.
List of Instrument, Biopsy devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Instrument, Biopsy devices (product code KNW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →