Curaway
Semi-Automatic Core Biopsy Instrument
9manufacturers in China registered for this device type
910catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Curaway Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Plexus (Xiamen) Co., Ltd., | Xiamen | Fujian | Contract manufacturer | 3 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Carbon (Shenzhen) Medical Device Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Zhejiang Curaway Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Contract manufacturer, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K241793 |
| Record published | 2026-06-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, pack of 5, pack of 8, pack of 9, pack of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BN-OCR-5/1615 | In distribution | |
| BN-OCR-5/1420/I | In distribution | |
| BN-OCR-4/1816/I | In distribution | |
| BN-OCR-2/1616 | In distribution | |
| BN-MAR-5/15033 | In distribution | |
| BN-MAR-6/17100 | In distribution | |
| BN-MAR-6/15113 | In distribution | |
| BN-OCR-9/1425 | In distribution | |
| BN-OCR-9/1825/I | In distribution | |
| BN-MAR-6/13200 | In distribution | |
| BN-OCR-8/1818/I | In distribution | |
| BN-OCR-2/2008 | In distribution | |
| BN-OCR-6/1818/I | In distribution | |
| BN-OCR-8/1618/I | In distribution | |
| BN-OCR-5/1820/I | In distribution | |
| BN-OCR-4/1825/I | In distribution | |
| BN-OCR-6/1620/I | In distribution | |
| BN-OCR-8/1813/I | In distribution | |
| BN-OCR-4/2016 | In distribution | |
| BN-MAR-5/17079 | In distribution | |
| BN-MAR-6/13029 | In distribution | |
| BN-MAR-6/17133 | In distribution | |
| BN-OCR-6/1408 | In distribution | |
| BN-OCR-5/2020/I | In distribution | |
| BN-MAR-6/19150 | In distribution | |
| BN-OCR-7/1608/I | In distribution | |
| BN-MAR-6/17149 | In distribution | |
| BN-MAR-6/15053 | In distribution | |
| BN-OCR-6/1615/I | In distribution | |
| BN-OCR-5/1820 | In distribution | |
| BN-MAR-5/19056 | In distribution | |
| BN-MAR-6/15216 | In distribution | |
| BN-MAR-5/15109 | In distribution | |
| BN-OCR-2/1410/I | In distribution | |
| BN-OCR-2/1415 | In distribution | |
| BN-OCR-4/1615 | In distribution | |
| BN-OCR-7/1410 | In distribution | |
| BN-MAR-6/15046 | In distribution | |
| BN-MAR-6/19166 | In distribution | |
| BN-OCR-3/1813/I | In distribution | |
| BN-OCR-9/1415/I | In distribution | |
| BN-OCR-2/1618/I | In distribution | |
| BN-MAR-5/13080 | In distribution | |
| BN-OCR-9/1410/I | In distribution | |
| BN-MAR-5/17133 | In distribution | |
| BN-OCR-9/1409/I | In distribution | |
| BN-OCR-7/1815 | In distribution | |
| BN-OCR-9/1616/I | In distribution | |
| BN-OCR-7/1615 | In distribution | |
| BN-OCR-2/1813/I | In distribution | |
| BN-OCR-2/1815 | In distribution | |
| BN-OCR-2/1418/I | In distribution | |
| BN-OCR-3/1616/I | In distribution | |
| BN-MAR-6/13049 | In distribution | |
| BN-OCR-9/1618/I | In distribution | |
| BN-MAR-5/19203 | In distribution | |
| BN-OCR-9/1416/I | In distribution | |
| BN-OCR-9/1416 | In distribution | |
| BN-OCR-4/1815/I | In distribution | |
| BN-OCR-1/1620 | In distribution | |
| BN-MAR-6/19200 | In distribution | |
| BN-OCR-7/1613 | In distribution | |
| BN-MAR-5/13110 | In distribution | |
| BN-OCR-1/2020/I | In distribution | |
| BN-OCR-6/1620 | In distribution | |
| BN-OCR-5/2020 | In distribution | |
| BN-OCR-2/1825 | In distribution | |
| BN-OCR-7/2010 | In distribution | |
| BN-OCR-6/2020 | In distribution | |
| BN-OCR-1/1418/I | In distribution | |
| BN-OCR-1/1808/I | In distribution | |
| BN-OCR-3/2008 | In distribution | |
| BN-OCR-7/1813 | In distribution | |
| BN-OCR-2/1810 | In distribution | |
| BN-MAR-6/15110 | In distribution | |
| BN-OCR-1/1610 | In distribution | |
| BN-OCR-8/2020/I | In distribution | |
| BN-OCR-3/1813 | In distribution | |
| BN-MAR-6/19033 | In distribution | |
| BN-OCR-9/1420/I | In distribution | |
| BN-MAR-6/19040 | In distribution | |
| BN-OCR-5/1620 | In distribution | |
| BN-OCR-1/1609/I | In distribution | |
| BN-OCR-9/1816 | In distribution | |
| BN-OCR-7/2015 | In distribution | |
| BN-OCR-1/1413 | In distribution | |
| BN-OCR-7/1609/I | In distribution | |
| BN-MAR-5/13200 | In distribution | |
| BN-OCR-4/1409 | In distribution | |
| BN-OCR-2/2013 | In distribution | |
| BN-OCR-1/1409/I | In distribution | |
| BN-OCR-2/1808/I | In distribution | |
| BN-OCR-2/1625 | In distribution | |
| BN-OCR-4/2010 | In distribution | |
| BN-OCR-6/1820/I | In distribution | |
| BN-OCR-6/1410 | In distribution | |
| BN-OCR-7/1809 | In distribution | |
| BN-OCR-2/1620 | In distribution | |
| BN-OCR-3/1618/I | In distribution | |
| BN-OCR-4/1425 | In distribution | |
| BN-OCR-3/2010/I | In distribution | |
| BN-MAR-6/13050 | In distribution | |
| BN-OCR-1/1813/I | In distribution | |
| BN-OCR-6/1808 | In distribution | |
| BN-MAR-5/13056 | In distribution | |
| BN-MAR-6/15130 | In distribution | |
| BN-OCR-5/1615/I | In distribution | |
| BN-OCR-1/1808 | In distribution | |
| BN-OCR-2/2025 | In distribution | |
| BN-OCR-5/1809 | In distribution | |
| BN-OCR-8/2010/I | In distribution | |
| BN-OCR-3/2009 | In distribution | |
| BN-OCR-6/1608/I | In distribution | |
| BN-MAR-6/17199 | In distribution | |
| BN-MAR-5/19040 | In distribution | |
| BN-OCR-2/2020 | In distribution | |
| BN-OCR-8/1616 | In distribution | |
| BN-OCR-8/1608/I | In distribution | |
| BN-OCR-1/1618 | In distribution | |
| BN-OCR-8/2009/I | In distribution | |
| BN-OCR-4/1610/I | In distribution | |
| BN-MAR-5/17096 | In distribution | |
| BN-OCR-1/2015/I | In distribution | |
| BN-OCR-6/2009 | In distribution | |
| BN-MAR-5/15079 | In distribution | |
| BN-OCR-9/2008 | In distribution | |
| BN-MAR-6/19149 | In distribution | |
| BN-MAR-6/15030 | In distribution | |
| BN-OCR-3/1408/I | In distribution | |
| BN-MAR-5/13096 | In distribution | |
| BN-MAR-5/17200 | In distribution | |
| BN-OCR-6/1809 | In distribution | |
| BN-OCR-2/1818 | In distribution | |
| BN-MAR-6/19056 | In distribution | |
| BN-OCR-2/1816 | In distribution | |
| BN-OCR-8/2009 | In distribution | |
| BN-OCR-7/1413 | In distribution | |
| BN-OCR-3/1625/I | In distribution | |
| BN-OCR-7/2009 | In distribution | |
| BN-MAR-5/13199 | In distribution | |
| BN-MAR-6/13126 | In distribution | |
| BN-OCR-9/1418 | In distribution | |
| BN-OCR-4/1825 | In distribution | |
| BN-MAR-5/13116 | In distribution | |
| BN-OCR-6/2016 | In distribution | |
| BN-OCR-6/1413/I | In distribution | |
| BN-OCR-9/2020/I | In distribution | |
| BN-OCR-5/1618 | In distribution | |
| BN-OCR-5/2025 | In distribution | |
| BN-OCR-6/1816/I | In distribution | |
| BN-MAR-5/13150 | In distribution | |
| BN-OCR-2/2009/I | In distribution | |
| BN-OCR-9/1808/I | In distribution | |
| BN-MAR-5/13103 | In distribution | |
| BN-OCR-2/1413 | In distribution | |
| BN-MAR-6/13066 | In distribution | |
| BN-OCR-1/1810/I | In distribution | |
| BN-OCR-5/1625 | In distribution | |
| BN-MAR-5/19133 | In distribution | |
| BN-OCR-1/1420 | In distribution | |
| BN-OCR-9/2008/I | In distribution | |
| BN-MAR-6/13203 | In distribution | |
| BN-OCR-8/1820/I | In distribution | |
| BN-OCR-4/1808/I | In distribution | |
| BN-OCR-9/2018/I | In distribution | |
| BN-MAR-5/19126 | In distribution | |
| BN-OCR-7/1613/I | In distribution | |
| BN-OCR-9/1818/I | In distribution | |
| BN-MAR-6/15066 | In distribution | |
| BN-OCR-3/1409/I | In distribution | |
| BN-OCR-7/2013 | In distribution | |
| BN-MAR-6/19109 | In distribution | |
| BN-OCR-7/2016/I | In distribution | |
| BN-OCR-9/2013/I | In distribution | |
| BN-OCR-8/2010 | In distribution | |
| BN-MAR-5/17146 | In distribution | |
| BN-OCR-1/2008 | In distribution | |
| BN-OCR-2/1425/I | In distribution | |
| BN-OCR-5/1413/I | In distribution | |
| BN-MAR-6/13043 | In distribution | |
| BN-OCR-2/1409 | In distribution | |
| BN-MAR-5/15110 | In distribution | |
| BN-OCR-3/1410 | In distribution | |
| BN-OCR-1/1810 | In distribution | |
| BN-OCR-7/2010/I | In distribution | |
| BN-OCR-5/1608/I | In distribution | |
| BN-OCR-8/2025 | In distribution | |
| BN-MAR-6/17103 | In distribution | |
| BN-OCR-6/2025 | In distribution | |
| BN-MAR-5/17203 | In distribution | |
| BN-MAR-5/15050 | In distribution | |
| BN-MAR-6/19216 | In distribution | |
| BN-MAR-5/19216 | In distribution | |
| BN-MAR-6/17050 | In distribution | |
| BN-OCR-9/1408 | In distribution | |
| BN-OCR-4/1810 | In distribution | |
| BN-OCR-1/1418 | In distribution | |
| BN-OCR-7/1608 | In distribution | |
| BN-OCR-3/1610/I | In distribution | |
| BN-MAR-5/15066 | In distribution | |
| BN-OCR-3/2009/I | In distribution | |
| BN-MAR-6/19203 | In distribution | |
| BN-OCR-1/2016 | In distribution | |
| BN-OCR-4/2018 | In distribution | |
| BN-MAR-6/15079 | In distribution | |
| BN-OCR-9/2015/I | In distribution | |
| BN-OCR-7/2009/I | In distribution | |
| BN-OCR-9/2016/I | In distribution | |
| BN-MAR-6/17066 | In distribution | |
| BN-MAR-6/13199 | In distribution | |
| BN-OCR-3/1425 | In distribution | |
| BN-OCR-3/1410/I | In distribution | |
| BN-OCR-9/1625/I | In distribution | |
| BN-MAR-5/15203 | In distribution | |
| BN-OCR-8/1420 | In distribution | |
| BN-OCR-7/1410/I | In distribution | |
| BN-MAR-5/13133 | In distribution | |
| BN-MAR-5/19083 | In distribution | |
| BN-OCR-2/1610/I | In distribution | |
| BN-MAR-5/15100 | In distribution | |
| BN-OCR-3/2016 | In distribution | |
| BN-OCR-5/1808/I | In distribution | |
| BN-MAR-5/19199 | In distribution | |
| BN-OCR-4/1809 | In distribution | |
| BN-OCR-9/1415 | In distribution | |
| BN-OCR-4/1818 | In distribution | |
| BN-OCR-7/1415 | In distribution | |
| BN-OCR-7/1620/I | In distribution | |
| BN-OCR-6/1615 | In distribution | |
| BN-MAR-6/19029 | In distribution | |
| BN-OCR-7/1420/I | In distribution | |
| BN-OCR-4/2008 | In distribution | |
| BN-MAR-5/15166 | In distribution | |
| BN-OCR-7/1616 | In distribution | |
| BN-OCR-4/1618 | In distribution | |
| BN-OCR-1/1415/I | In distribution | |
| BN-OCR-1/1409 | In distribution | |
| BN-OCR-2/1415/I | In distribution | |
| BN-OCR-9/1413/I | In distribution | |
| BN-OCR-8/2025/I | In distribution | |
| BN-OCR-1/1609 | In distribution | |
| BN-OCR-2/1615 | In distribution | |
| BN-MAR-6/13116 | In distribution | |
| BN-OCR-4/1616 | In distribution | |
| BN-OCR-2/2018 | In distribution | |
| BN-OCR-7/1816 | In distribution | |
| BN-OCR-9/2009 | In distribution | |
| BN-OCR-4/1816 | In distribution | |
| BN-OCR-3/1809/I | In distribution | |
| BN-OCR-8/1820 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SureAim Coaxial Biopsy Needle | Canyon Medical Inc. | 157 |
| CorVocet™ | Merit Medical Systems, Inc. | 157 |
| SureCore Automatic Disposable Biopsy Needle | Canyon Medical Inc. | 156 |
| M Biopsy Automatic Disposable Biopsy Needle | Canyon Medical Inc. | 108 |
| M Biopsy Coaxial Biopsy Needle | Canyon Medical Inc. | 89 |
| Co-Axial Introducer Needle | Argon Medical Devices, Inc. | 80 |
| SureCore Semi-automatic Disposable Biopsy Needle | Canyon Medical Inc. | 76 |
| Invivo | Philips DS North America LLC | 71 |
| Coaxial needle | Möller Medical GmbH | 68 |
| Disposable needle for reusable biopsy gun | Möller Medical GmbH | 62 |
| Remington Medical, Inc. Automatic Cutting Needle (NAC) | Remington Medical, Inc. | 60 |
| M-Biopsy | Mermaid Medical A/S | 58 |
Showing 12 of 692. All products under Instrument, Biopsy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260517 | 2026-08-28 |
| K244018 | 2025-07-22 |
| K241793 | 2025-01-24 |
| K242322 | 2025-01-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.