AprioCore Plus
AprioCore Plus is a manually operated, semi-automatic spring-loaded needle for image-guided core biopsy of soft tissue. Its inner stylet has a specimen notch, while the beveled needle and…
AprioCore Plus is a manually operated, semi-automatic spring-loaded needle for image-guided core biopsy of soft tissue. Its inner stylet has a specimen notch, while the beveled needle and centimeter markings assist placement. The distal tip is echogenic for ultrasound visualization.
The needle is also visible with CT and fluoroscopy. Indicated sampling sites include breast, kidney, liver, lung, thyroid, lymph nodes and other soft-tissue masses. Direct patient-contacting materials are AISI 304 and AISI 302 stainless steel.
Listed Item
AprioCore plus is a sterile, disposable, semi-automatic, spring-loaded biopsy needle.
Coaxial Compatibility and Supply
The needle is compatible with AprioMed Gangi-SoftGuard and Gangi-HydroGuard coaxial needles. It is available in different gauges and lengths and supplied sterile for single use. Its housing permits different hand positions during manual operation.
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 | AprioMed AB, Sweden |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K193268 |
| Record published | 2020-03-23 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Shelf box of 5, transportation box of 12 |
| Sizes | Length 8.5 to 19.5 cm; needle gauge 16 to 18 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACP18-185-10 | Length 18.5 cm | In distribution |
| ACP18-195-20 | Length 19.5 cm | In distribution |
| ACP16-095-20 | Length 9.5 cm | In distribution |
| ACP16-135-10 | Length 13.5 cm | In distribution |
| ACP16-085-10 | Length 8.5 cm | In distribution |
| ACP18-095-20 | Length 9.5 cm | In distribution |
| ACP16-145-20 | Length 14.5 cm | In distribution |
| ACP16-195-20 | Length 19.5 cm | In distribution |
| ACP18-085-10 | Length 8.5 cm | In distribution |
| ACP18-145-20 | Length 14.5 cm | In distribution |
| ACP18-135-10 | Length 13.5 cm | In distribution |
| ACP16-185-10 | Length 18.5 cm | 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 |
| 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 |
Showing 12 of 692. All products under Instrument, Biopsy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K193268 | 2020-02-27 |
| K150625 | 2015-06-09 |
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.