SureCore Semi-Automatic Disposable Biopsy Needle
The SureCore semi-automatic disposable biopsy needle obtains soft tissue samples for pathological examination. It is intended for tissues such as liver, kidney, prostate, spleen, lung,…
The SureCore semi-automatic disposable biopsy needle obtains soft tissue samples for pathological examination. It is intended for tissues such as liver, kidney, prostate, spleen, lung, thyroid and lymph nodes, and is not intended for bone biopsy.
The operator manually advances the inner needle to expose its specimen notch. Pressing the plunger releases a spring mechanism that rapidly advances the outer cutting cannula over the notch, capturing the tissue sample.
Listed Item
Semi-automatic Disposable Biopsy Needle
Image Guidance and Supply
Sampling is performed with appropriate imaging guidance such as ultrasound, X-ray or CT. The device cannot be used under MRI and is supplied sterile for a single use.
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 | Canyon Medical Inc., China |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Manufacturer |
| 510(k) | K222865 |
| Record published | 2023-06-19 |
| Record revised | 2024-01-26 (version 2) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BN-2/181300-2 | In distribution | |
| BN-2/142000 | In distribution | |
| BN-2/161300-1 | In distribution | |
| BN-2/201600 | In distribution | |
| BN-2/201300-1 | In distribution | |
| BN-2/160600 | In distribution | |
| BN-2/141800-2 | In distribution | |
| BN-2/162000-2 | In distribution | |
| BN-2/142000-2 | In distribution | |
| BN-2/161800-1 | In distribution | |
| BN-2/163000-1 | In distribution | |
| BN-2/182500-1 | In distribution | |
| BN-2/201000 | In distribution | |
| BN-2/143000-2 | In distribution | |
| BN-2/161000-2 | In distribution | |
| BN-2/162000 | In distribution | |
| BN-2/181600-1 | In distribution | |
| BN-2/182500 | In distribution | |
| BN-2/201300-2 | In distribution | |
| BN-2/202500 | In distribution | |
| BN-2/163000 | In distribution | |
| BN-2/182000-2 | In distribution | |
| BN-2/161000 | In distribution | |
| BN-2/161600-1 | In distribution | |
| BN-2/142000-1 | In distribution | |
| BN-2/181800-2 | In distribution | |
| BN-2/143000-1 | In distribution | |
| BN-2/201600-1 | In distribution | |
| BN-2/161800-2 | In distribution | |
| BN-2/181000-1 | In distribution | |
| BN-2/181300 | In distribution | |
| BN-2/202000-1 | In distribution | |
| BN-2/141000-1 | In distribution | |
| BN-2/161600-2 | In distribution | |
| BN-2/180600 | In distribution | |
| BN-2/140600 | In distribution | |
| BN-2/141600 | In distribution | |
| BN-2/162000-1 | In distribution | |
| BN-2/141000 | In distribution | |
| BN-2/141600-2 | In distribution | |
| BN-2/141800-1 | In distribution | |
| BN-2/200600 | In distribution | |
| BN-2/202500-1 | In distribution | |
| BN-2/141600-1 | In distribution | |
| BN-2/201000-1 | In distribution | |
| BN-2/161300 | In distribution | |
| BN-2/141800 | In distribution | |
| BN-2/181800-1 | In distribution | |
| BN-2/182000 | In distribution | |
| BN-2/141300 | In distribution | |
| BN-2/161300-2 | In distribution | |
| BN-2/141000-2 | In distribution | |
| BN-2/141300-1 | In distribution | |
| BN-2/181000 | In distribution | |
| BN-2/201300 | In distribution | |
| BN-2/181300-1 | In distribution | |
| BN-2/181000-2 | In distribution | |
| BN-2/141300-2 | In distribution | |
| BN-2/181600-2 | In distribution | |
| BN-2/202500-2 | In distribution | |
| BN-2/201800-2 | In distribution | |
| BN-2/202000-2 | In distribution | |
| BN-2/201800 | In distribution | |
| BN-2/161000-1 | In distribution | |
| BN-2/181600 | In distribution | |
| BN-2/143000 | In distribution | |
| BN-2/201000-2 | In distribution | |
| BN-2/182000-1 | In distribution | |
| BN-2/182500-2 | In distribution | |
| BN-2/181800 | In distribution | |
| BN-2/201800-1 | In distribution | |
| BN-2/161800 | In distribution | |
| BN-2/161600 | In distribution | |
| BN-2/163000-2 | In distribution | |
| BN-2/202000 | In distribution | |
| BN-2/201600-2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaway | Zhejiang Curaway Medical Technology Co., Ltd. | 910 |
| 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 |
| 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 |
|---|---|
| K233031 | 2024-01-17 |
| K222865 | 2023-04-03 |
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.