510(k) K260365
- Device
- 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
- Applicant
- Devicor Medical Products, Inc.
- 510(k) number
- K260365
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-04
- Date received
- 2026-02-04
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Jamie Edenborg
- Address
- 300 E Business Way Fifth Floor Cincinnati OH US 45241 45241
FDA Registration Numbers#
- 3018507299
- 1224960
- 3021023752
- 3005580113
- 3017210488
- 3007137598
- 1219114
- 1526711
- 3030626857
- 3008262715
- 3038611181
- 3010097171
- 1835568
- 9617592
- 3010220595
- 3016844398
- 3006849754
- 2029275
- 3004111573
- 3010041511
- 1644312
- 9617616
- 1820334
- 3012447612
- 2648623
- 3004122598
- 3004774118
- 3030733800
- 3015980719
- 1419411
- 1643817
- 3006788678
- 3033858858
- 2020394
- 1048735
- 1319660
- 1450662
- 3008773560
- 3015309643
- 3012470322
- 3012495575
- 2531475
- 1722746
- 3007513241
- 2032098
- 3010082909
- 3003500271
- 3004636440
- 3002808022
- 3030446844
- 3013462478
- 3015974593
- 3004681601
- 9680794
- 3007664053
- 3044399745
- 9680904
- 3008992312
- 1018233
- 3011245468
- 3014408997
- 3009050824
- 3004749705
- 1424263
- 3004024955
- 9611680
- 3010273872
- 3033589330
- 3015225571
- 3006981798
- 1724474
- 1000393132
- 1528319
- 3027260597
- 3011642792
- 2183613
- 3008496839
- 1649518
- 3011137372
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 |
| 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 |
| K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) | Xaga Surgical | 2025-02-27 |