510(k) K071048
- Device
- RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537
- Applicant
- RUBICOR MEDICAL, INC.
- 510(k) number
- K071048
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-05-15
- Date received
- 2007-04-13
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT J CHIN
- Address
- 25 Hartford Ave. San Carlos CA US 94070 94070
FDA Registration Numbers#
- 3005216725
- 3030733800
- 1223821
- 3010041511
- 3030626857
- 3012447612
- 3030446844
- 3006082230
- 3015173212
- 3005636544
- 1450662
- 3008992312
- 2030624
- 3004749705
- 3007137598
- 1222168
- 3012536737
- 1721504
- 2020394
- 3015980719
- 1061927
- 3012495575
- 2022435
- 9680904
- 3008496839
- 3038611181
- 3017636737
- 2649614
- 3016688836
- 1018233
- 2953359
- 3013557562
- 1625425
- 1643817
- 1423507
- 3011137372
- 1056129
- 3002808022
- 1226146
- 3010273872
- 3005496266
- 3011504993
- 3004122598
- 3015142721
- 1644312
- 9680794
- 3007648417
- 1224960
- 1054811
- 3018507299
- 3015974593
- 1625685
- 3044026004
- 3007014520
- 1219930
- 3013440400
- 1000484830
- 3015136750
- 2133772
- 3006330030
- 3015225571
- 3004105270
- 1921846
- 3007664053
- 3009265194
- 3017210488
- 3007738736
- 9680340
- 3003500271
- 3004962788
- 2648727
- 1721983
- 1056553
- 1424263
- 1048735
- 3021023752
- 1720929
- 1528319
- 3009423112
- 3004636440
Source Documents#
Other 510(k) Records For Product Code KNW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260517 | Automatic Core Biopsy Instrument | Zhejiang Curaway Medical Technology Co., Ltd. | 2026-08-28 |
| K262571 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2026-08-14 |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) | Hologic, Inc. | 2026-08-12 |
| K260572 | Marrow Marxman | Medimetrix, LLC | 2026-08-04 |
| K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-12 |
| K260365 | Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char | Devicor Medical Products, Inc. | 2026-03-04 |
| K252795 | ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial | Argon Medical Devices, Inc. | 2026-02-23 |
| K252681 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | Bard Peripheral Vascular, Inc. | 2025-12-12 |
| K252183 | Resitu Slider 09 (RESL09) | Resitu Medical AB | 2025-09-24 |
| K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | 2025-07-29 |
| K244018 | Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-07-22 |
| K243296 | Disposable Biopsy Needle | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-07-11 |
| K250032 | Marquee™ Disposable Core Biopsy Instrument and Instrument Kit | Bard Peripheral Vascular, Inc. | 2025-07-10 |
| K243886 | ExpressCore Biopsy Device | Inrad, Inc. | 2025-04-29 |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2025-04-24 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases