Vivant Breast Lesion Localization Device
FDA 510(k) K003439 · Vivant Medical, Inc.
510(k) numberK003439
Submission
- Device name
- Vivant Breast Lesion Localization Device
- Applicant
- Vivant Medical, Inc.
Portola Valley, CA, US - Received
- November 6, 2000
- Decision date
- December 15, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K050223 | Vivawave Microwave Ablation System, Coaxial IntroducerGEI · Special | 02/24/2005SE |
| K040279 | Vivaring Microwave Ablation ProbeGEI · Special | 03/02/2004SE |
| K032702 | Vivatip Microwave Ablation ProbeGEI · Special | 10/03/2003SE |
| K032047 | Tri-Loop Microwave Ablation ProbeGEI · Special | 08/06/2003SE |
| K031556 | Vivatherm Themperature Measurement SystemFLL · Traditional | 06/23/2003SE |
| K023311 | Loop Microwave Ablation ProbeGEI · Traditional | 04/09/2003SE |
| K022286 | Encircle Localization DeviceKNW · Traditional | 10/11/2002SE |
| K011676 | Vivawave Microwave SystemNEY · Traditional | 06/18/2002SE |
| K000278 | Vivant Medical Biopsy Marker SystemFZP · Traditional | 06/23/2000SE |
Questions and answers
When was Vivant Breast Lesion Localization Device cleared by the FDA?
Vivant Breast Lesion Localization Device (K003439) received a 510(k) decision of Substantially Equivalent on December 15, 2000, 39 days after the submission was received.
What is the product code of K003439?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.