EnCor EnCompass Breast Biopsy and Tissue Removal System
FDA 510(k) K262571 · Bard Peripheral Vascular, Inc.
510(k) numberK262571
Submission
- Device name
- EnCor EnCompass Breast Biopsy and Tissue Removal System
- Applicant
- Bard Peripheral Vascular, Inc.
Tempe, AZ, US - Received
- July 24, 2026
- Decision date
- August 14, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260517 | Automatic Core Biopsy InstrumentKNW · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 08/28/2026SE |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW · Special | Hologic, Inc. | 08/12/2026SE |
| K260572 | Marrow MarxmanKNW · Traditional | Medimetrix, LLC | 08/04/2026SE |
| K261196 | Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special | Promisemed Hangzhou Meditech Co., Ltd. | 05/12/2026SE |
| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome…KNW · Traditional | Devicor Medical Products, Inc. | 03/04/2026SE |
| K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…KNW · Traditional | Argon Medical Devices, Inc. | 02/23/2026SE |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Traditional | Bard Peripheral Vascular, Inc. | 12/12/2025SE |
| K252183 | Resitu Slider 09 (RESL09)KNW · Traditional | Resitu Medical AB | 09/24/2025SE |
| K243407 | Forcyte Autograft Harvest KitKNW · Traditional | Forcyte Medical, LLC | 07/29/2025SE |
| K244018 | Disposable Biopsy NeedleKNW · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 07/22/2025SE |
More from Zhejiang Curaway Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260012 | UltraScore Focused Force PTA BalloonPNO · Special | 02/04/2026SE |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Traditional | 12/12/2025SE |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument KitKNW · Special | 07/10/2025SE |
| K250219 | Dorado PTA Balloon Dilatation CatheterDQY · Traditional | 06/17/2025SE |
| K243642 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | 03/24/2025SE |
| K242757 | Rotarex Atherectomy SystemMCW · Special | 01/30/2025SE |
| K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal…PNG · Traditional | 12/06/2024SE |
| K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG…LJT · Special | 12/08/2023SE |
| K221440 | Liverty TIPS Access SetDYB · Traditional | 05/31/2022SE |
| K213896 | BD Trek Powered Bone Biopsy SystemKNW · Traditional | 03/30/2022SE |
Questions and answers
When was EnCor EnCompass Breast Biopsy and Tissue Removal System cleared by the FDA?
EnCor EnCompass Breast Biopsy and Tissue Removal System (K262571) received a 510(k) decision of Substantially Equivalent on August 14, 2026, 21 days after the submission was received.
What is the product code of K262571?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.