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 Zhejiang Curaway Medical Technology Co., Ltd., Senorx, Inc. and Promisemed Hangzhou Meditech Co., Ltd..
FDA 510(k) Cleared Instrument, Biopsy Devices (Product Code KNW)
About Product Code KNW - Regulatory Context
510(k) Submission Activity
360 total 510(k) submissions under product code KNW since 1976, with 360 receiving FDA clearance (average review time: 99 days).
Submission volume has increased in recent years - 18 submissions in the last 24 months compared to 13 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under KNW have taken an average of 160 days to reach a decision - up from 95 days historically. Manufacturers should account for longer review timelines in current project planning.
KNW devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →