Rubicor Magic Breast Biopsy Device, Model 31537
FDA 510(k) K071048 · Rubicor Medical, Inc.
510(k) numberK071048
Submission
- Device name
- Rubicor Magic Breast Biopsy Device, Model 31537
- Applicant
- Rubicor Medical, Inc.
San Carlos, CA, US - Received
- April 13, 2007
- Decision date
- May 15, 2007
- 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 |
|---|---|---|
| K070275 | Flexible Loop Electrosurgical ElectrodeGEI · Traditional | 03/09/2007SE |
| K053151 | Rubicor Magic Breast Biopsy DeviceKNW · Traditional | 11/18/2005SE |
| K052506 | Rubicor Encapsule Breast Biopsy Device, Model 31108GEI · Special | 10/06/2005SE |
| K032584 | Rubicor Encapsule Breast Biopsy Device, Model 30629GEI · Special | 09/17/2003SE |
| K030049 | Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086GEI · Special | 01/29/2003SE |
| K023601 | Rubicor Encapsule Breast Biopsy Device, Model 30086GEI · Special | 11/19/2002SE |
| K020047 | Rubicor Breast Biopsy DeviceGEI · Traditional | 04/05/2002SE |
Questions and answers
When was Rubicor Magic Breast Biopsy Device, Model 31537 cleared by the FDA?
Rubicor Magic Breast Biopsy Device, Model 31537 (K071048) received a 510(k) decision of Substantially Equivalent on May 15, 2007, 32 days after the submission was received.
What is the product code of K071048?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.