Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012
FDA 510(k) K080171 · Sanarus Medical, Inc.
510(k) numberK080171
Submission
- Device name
- Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012
- Applicant
- Sanarus Medical, Inc.
Pleasanton, CA, US - Received
- January 24, 2008
- Decision date
- March 6, 2008
- 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
Other 510(k)s with product code KNW
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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 |
More from Forcyte Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K073533 | Sanarus V2 Treatment SystemGEH · Special | 02/07/2008SE |
| K062896 | V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600GEH · Traditional | 01/03/2007SE |
| K061510 | Sanarus Visica Treatment SystemGEH · Special | 07/18/2006SE |
| K052861 | Modification To:Sanarus Visica Treatment System , Models VS2000GEH · Special | 11/15/2005SE |
| K051581 | Sanarus Cassi II Rotational Core Biopsy System, Model CS2000KNW · Traditional | 07/27/2005SE |
| K042136 | Sanarus Cassi Rotational Core Biopsy SystemKNW · Special | 09/08/2004SE |
| K032506 | Sanarus Centrica II Rotational Core Biopsy SystemKNW · Traditional | 10/09/2003SE |
| K020054 | Sanarus Indica Marker SystemFZP · Traditional | 10/16/2002SE |
| K022314 | Sanarus Visica Treatment SystemGEH · Traditional | 10/15/2002SE |
| K022879 | Modification to Sanarus Centrica Core Tissue BiopsyKNW · Special | 09/23/2002SE |
Questions and answers
When was Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012 cleared by the FDA?
Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012 (K080171) received a 510(k) decision of Substantially Equivalent on March 6, 2008, 42 days after the submission was received.
What is the product code of K080171?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.