EnCor Breast Biopsy Probe with Rinse Tube
FDA 510(k) K210654 · Senorx, Inc.
510(k) numberK210654
Submission
- Device name
- EnCor Breast Biopsy Probe with Rinse Tube
- Applicant
- Senorx, Inc.
Tempe, AZ, US - Received
- March 4, 2021
- Decision date
- March 31, 2021
- 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 |
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | Bard Peripheral Vascular, Inc. | 08/14/2026SE |
| 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 |
More from Forcyte Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K233220 | EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver…KNW · Special | 10/27/2023SE |
| K161805 | EnCor MRI Introducer Set, EnCor Probe IntroducerKNW · Special | 07/19/2016SE |
| K131654 | Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue MarkerNEU · Special | 06/27/2013SE |
| K093512 | Encor Breast Biopsy SystemKNW · Traditional | 11/20/2009SE |
| K092323 | Contura Cavity Maintenance CatheterJAQ · Traditional | 08/19/2009SE |
| K082264 | Contura Lumen MarkerJAQ · Traditional | 09/12/2008SESU |
| K081085 | Starchmark Biopsy Site Marker, Model STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GSNEU · Traditional | 08/01/2008SE |
| K081170 | Prostate Tissue MarkerNEU · Traditional | 05/28/2008SE |
| K081079 | Contura MLB Source Applicator for BrachytherapyJAQ · Traditional | 05/02/2008SESU |
| K080791 | Contura Multi-Lumen Balloon Source Applicator for Brachytherapy, Models B001-45 and…JAQ · Traditional | 04/30/2008SESU |
Questions and answers
When was EnCor Breast Biopsy Probe with Rinse Tube cleared by the FDA?
EnCor Breast Biopsy Probe with Rinse Tube (K210654) received a 510(k) decision of Substantially Equivalent on March 31, 2021, 27 days after the submission was received.
What is the product code of K210654?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.