Product code KNW: 510(k) clearances and predicates

Product code KNW covers EnCor EnCompass™ Breast Biopsy and Tissue Removal System. FDA lists 365 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.

Clearance volume

365 clearances on file under product code KNW. Counts by year:

Year	Clearances
2022	8
2023	7
2024	5
2025	12
2026 so far	7

Recent clearances

Newest KNW clearances in the FDA index, with applicant and decision date:

• K260517, Automatic Core Biopsy Instrument, applicant Zhejiang Curaway Medical Technology Co., Ltd., decided 2026-08-28. FDA record
• K262571, EnCor EnCompass™ Breast Biopsy and Tissue Removal System, applicant Bard Peripheral Vascular, Inc., decided 2026-08-14. FDA record
• K262792, Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09), applicant Hologic, Inc., decided 2026-08-12. FDA record
• K260572, Marrow Marxman, applicant Medimetrix, LLC, decided 2026-08-04. FDA record
• K261196, Promisemed VeriEcto Automatic Biopsy Needles, applicant Promisemed Hangzhou Meditech Co., Ltd., decided 2026-05-12. FDA record
• K260365, Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char, applicant Devicor Medical Products, Inc., decided 2026-03-04. FDA record
• K252795, ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial, applicant Argon Medical Devices, Inc., decided 2026-02-23. FDA record
• K252681, EnCor EnCompass™ Breast Biopsy and Tissue Removal System, applicant Bard Peripheral Vascular, Inc., decided 2025-12-12. FDA record

What this means for a regulatory watcher

Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Automatic Core Biopsy Instrument, Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09). Watch new KNW clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.

FAQ

What is FDA product code KNW?

It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KNW clearances include EnCor EnCompass™ Breast Biopsy and Tissue Removal System.

How many 510(k) clearances use product code KNW?

365 at the time this page was generated, from openFDA records.

How do I find a predicate device under KNW?

Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.

How do I track new KNW clearances?

Get 510(k) alerts filtered to this product code and read each new clearance as it posts.

Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.