510(k) K203141
- Device
- Uramix CuraWay Biopsy Needle
- Applicant
- Uramix, Inc.
- 510(k) number
- K203141
- Product code
- KNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-09-17
- Date received
- 2020-10-20
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy
- Medical specialty
- Gastroenterology/Urology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Mooreville
- Address
- 272 N. Lansdowne Ave. Lansdowne PA US 19050 19050
FDA Registration Numbers#
- 9680794
- 3010966701
- 3000126629
- 3033858858
- 3006082230
- 1423662
- 3015967359
- 3006063136
- 8010312
- 3002808022
- 1211566
- 3012470322
- 3004201275
- 3030446844
- 3015225571
- 3015974593
- 3006786907
- 3007648417
- 3015980719
- 3027260597
- 3002806603
- 1226544
- 3004681601
- 2433012
- 3014032451
- 3004749705
- 3006849754
- 3009050824
- 3017448139
- 3005496266
- 1222780
- 9680904
- 3016050940
- 3019807891
- 1419411
- 3014408997
- 3001592626
- 2024311
- 1721676
- 3015142721
- 1220477
- 3004598644
- 1000112137
- 2528981
- 1417485
- 3008496839
- 1058584
- 3004111573
- 9611481
- 3016678045
- 3015806723
- 3012447612
- 3015309643
- 1123169
- 3005580113
- 3012536737
- 1625425
- 3004024955
- 3012936513
- 3006611221
- 1319639
- 2648666
- 1724474
- 3009423112
- 2133810
- 3015136750
- 1820334
- 3003500271
- 3015077548
- 9680340
- 2953359
- 3007200016
- 1825146
- 3008773560
- 1450662
- 3012495575
- 2183613
- 1643817
- 9611612
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#
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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