SureAim Coaxial Biopsy Needle
SureAim Coaxial Biopsy Needle is a guide assembly used with a separate biopsy needle to reach soft tissue under imaging control. The coaxial cannula provides an access path through which…
SureAim Coaxial Biopsy Needle is a guide assembly used with a separate biopsy needle to reach soft tissue under imaging control. The coaxial cannula provides an access path through which the sampling needle is introduced.
The guide is supplied with a trocar-tip stylet, with or without a blunt-tip needle. These components establish the guide path; tissue sampling is performed by the separate automatic or semiautomatic biopsy instrument.
Listed Item
Coaxial Biopsy Needle
Imaging and Supply
The range is intended for guidance with ultrasound, X-ray or CT and cannot be used under MRI. The devices are hand-operated and supplied sterile for single use, with guide and sampling-needle configurations performing different roles.
9manufacturers in China registered for this device type
157catalogue numbers in this listing
2510(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 | 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 | 2023-06-23 |
| Record revised | 2024-01-31 (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 |
|---|---|---|
| CN-18/48 | In distribution | |
| CN-17/89-1 | In distribution | |
| CN-15/128-1 | In distribution | |
| CN-13/159 | In distribution | |
| CN-15/50-1 | In distribution | |
| CN-15/198 | In distribution | |
| CN-17/48-1 | In distribution | |
| CN-15/128 | In distribution | |
| CN-17/128-1 | In distribution | |
| CN-18/128 | In distribution | |
| CN-17/89 | In distribution | |
| CN-18/78-1 | In distribution | |
| CN-17/139 | In distribution | |
| CN-15/59 | In distribution | |
| CN-17/148-1 | In distribution | |
| CN-19/59-1 | In distribution | |
| CN-15/139 | In distribution | |
| CN-16/139-1 | In distribution | |
| CN-18/48-1 | In distribution | |
| CN-16/50 | In distribution | |
| CN-16/78 | In distribution | |
| CN-19/119 | In distribution | |
| CN-17/148 | In distribution | |
| CN-19/139 | In distribution | |
| CN-15/159-1 | In distribution | |
| CN-15/100 | In distribution | |
| CN-14/139 | In distribution | |
| CN-14/148 | In distribution | |
| CN-15/78 | In distribution | |
| CN-19/108-1 | In distribution | |
| CN-18/119-1 | In distribution | |
| CN-13/139 | In distribution | |
| CN-16/100-1 | In distribution | |
| CN-15/178 | In distribution | |
| CN-16/89 | In distribution | |
| CN-16/148-1 | In distribution | |
| CN-19/48-1 | In distribution | |
| CN-19/159 | In distribution | |
| CN-16/58-1 | In distribution | |
| CN-13/108-1 | In distribution | |
| CN-13/59-1 | In distribution | |
| CN-19/78 | In distribution | |
| CN-15/89 | In distribution | |
| CN-14/59 | In distribution | |
| CN-16/139 | In distribution | |
| CN-19/178-3 | In distribution | |
| CN-16/78-1 | In distribution | |
| CN-13/108 | In distribution | |
| CN-15/198-1 | In distribution | |
| CN-17/139-1 | In distribution | |
| CN-16/108 | In distribution | |
| CN-18/89-1 | In distribution | |
| CN-15/148 | In distribution | |
| CN-13/139-1 | In distribution | |
| CN-15/100-1 | In distribution | |
| CN-17/128 | In distribution | |
| CN-19/59 | In distribution | |
| CN-13/198-1 | In distribution | |
| CN-15/48-1 | In distribution | |
| CN-13/148-1 | In distribution | |
| CN-15/48 | In distribution | |
| CN-19/178-1 | In distribution | |
| CN-14/78 | In distribution | |
| CN-19/128-1 | In distribution | |
| CN-17/59-1 | In distribution | |
| CN-15/119 | In distribution | |
| CN-17/178 | In distribution | |
| CN-17/108 | In distribution | |
| CN-18/148-1 | In distribution | |
| CN-14/139-1 | In distribution | |
| CN-14/148-1 | In distribution | |
| CN-15/119-1 | In distribution | |
| CN-17/178-1 | In distribution | |
| CN-19/48 | In distribution | |
| CN-15/108 | In distribution | |
| CN-19/139-1 | In distribution | |
| CN-16/128-1 | In distribution | |
| CN-16/120-1 | In distribution | |
| CN-19/119-1 | In distribution | |
| CN-14/128 | In distribution | |
| CN-18/89 | In distribution | |
| CN-14/128-1 | In distribution | |
| CN-13/48-1 | In distribution | |
| CN-14/48-1 | In distribution | |
| CN-15/59-1 | In distribution | |
| CN-13/89-1 | In distribution | |
| CN-17/59 | In distribution | |
| CN-14/59-1 | In distribution | |
| CN-15/50 | In distribution | |
| CN-16/50-1 | In distribution | |
| CN-16/89-1 | In distribution | |
| CN-18/119 | In distribution | |
| CN-13/128 | In distribution | |
| CN-17/198-1 | In distribution | |
| CN-13/59 | In distribution | |
| CN-16/48-1 | In distribution | |
| CN-14/119-1 | In distribution | |
| CN-13/119 | In distribution | |
| CN-15/159 | In distribution | |
| CN-17/119-1 | In distribution | |
| CN-18/108 | In distribution | |
| CN-15/108-1 | In distribution | |
| CN-18/139 | In distribution | |
| CN-16/108-1 | In distribution | |
| CN-15/148-1 | In distribution | |
| CN-14/48 | In distribution | |
| CN-16/120 | In distribution | |
| CN-18/108-1 | In distribution | |
| CN-13/78 | In distribution | |
| CN-16/128 | In distribution | |
| CN-19/159-1 | In distribution | |
| CN-19/148-1 | In distribution | |
| CN-15/178-1 | In distribution | |
| CN-18/148 | In distribution | |
| CN-13/148 | In distribution | |
| CN-19/108 | In distribution | |
| CN-16/148 | In distribution | |
| CN-18/128-1 | In distribution | |
| CN-19/148 | In distribution | |
| CN-19/89-1 | In distribution | |
| CN-13/198 | In distribution | |
| CN-15/89-1 | In distribution | |
| CN-14/108 | In distribution | |
| CN-13/89 | In distribution | |
| CN-13/128-1 | In distribution | |
| CN-14/89 | In distribution | |
| CN-15/78-1 | In distribution | |
| CN-13/119-1 | In distribution | |
| CN-17/198 | In distribution | |
| CN-17/78 | In distribution | |
| CN-13/78-1 | In distribution | |
| CN-19/178 | In distribution | |
| CN-19/198 | In distribution | |
| CN-18/78 | In distribution | |
| CN-18/59 | In distribution | |
| CN-18/139-1 | In distribution | |
| CN-14/78-1 | In distribution | |
| CN-17/108-1 | In distribution | |
| CN-15/139-1 | In distribution | |
| CN-17/48 | In distribution | |
| CN-19/128 | In distribution | |
| CN-18/59-1 | In distribution | |
| CN-16/58 | In distribution | |
| CN-13/48 | In distribution | |
| CN-17/119 | In distribution | |
| CN-17/159-1 | In distribution | |
| CN-17/78-1 | In distribution | |
| CN-19/89 | In distribution | |
| CN-14/89-1 | In distribution | |
| CN-19/78-1 | In distribution | |
| CN-13/159-1 | In distribution | |
| CN-17/159 | In distribution | |
| CN-16/100 | In distribution | |
| CN-14/119 | In distribution | |
| CN-19/198-1 | In distribution | |
| CN-14/108-1 | In distribution | |
| CN-16/48 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaway | Zhejiang Curaway Medical Technology Co., Ltd. | 910 |
| 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 |
|---|---|
| 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.