SuperCore™ Biopsy Instrument
SuperCore™ Biopsy Instrument 14ga x 15cm (use with Optional Co-Axial Needle MCXS1415LXM)
9manufacturers in China registered for this device type
34catalogue numbers in this listing
2510(k) clearances naming this product code
11recalls on this 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 | Argon Medical Devices, Inc., United States |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-16 |
| Record revised | 2026-05-11 (version 5) |
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 |
| Storage | Special storage condition: Keep dry and away from sunlight |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 701220200 | Co-Axial Introducer Needle: 19ga x 15.2cm | In distribution |
| 701214090 | Co-Axial Introducer Needle: 13ga x 3.9cm | In distribution |
| 701214150 | Co-Axial Introducer Needle: 13ga x 9.9cm | In distribution |
| 701116060M | 16ga x 6cm | In distribution |
| 701116060 | 16ga x 6cm | In distribution |
| 701118060 | 18ga x 6cm | In distribution |
| 701116150 | 16ga x 15cm | In distribution |
| 701120150 | 20ga x 15cm | In distribution |
| 701218200 | Co-Axial Introducer Needle: 17ga x 14.9cm | In distribution |
| 701114060M | 14ga x 6cm | In distribution |
| 701118150 | 18ga x 15cm | In distribution |
| 701220150 | Co-Axial Introducer Needle: 19ga x 10.2cm | In distribution |
| 701114200 | 14ga x 20cm | In distribution |
| 701114090M | 14ga x 9cm | In distribution |
| 701118200 | 18ga x 20cm | In distribution |
| 701218150 | Co-Axial Introducer Needle: 17ga x 9.9cm | In distribution |
| 701116090M | 16ga x 9cm | In distribution |
| 701216090 | Co-Axial Introducer Needle: 15ga x 3.9cm | In distribution |
| 701114060 | 14ga x 6cm | In distribution |
| 701120090 | 20ga x 9cm | In distribution |
| 701120060 | 20ga x 6cm | In distribution |
| 701114150M | 14ga x 15cm | In distribution |
| 701114090 | 14ga x 9cm | In distribution |
| 701218090 | Co-Axial Instrument Needle: 17ga x 3.9cm | In distribution |
| 701120200 | 20ga x 20cm | In distribution |
| 701216150 | Co-Axial Introducer Needle: 15ga x 9.9cm | In distribution |
| 701220090 | Co-Axial Introducer Needle: 19ga x 4.2cm | In distribution |
| 701118090 | 18ga x 9cm | In distribution |
| 701216200 | Co-Axial Introducer Needle: 15ga x 14.9cm | In distribution |
| 701116200 | 16ga x 20cm | In distribution |
| 701116150M | 16ga x 15cm | In distribution |
| 701214200 | Co-Axial Introducer Needle: 13ga x 14.9cm | In distribution |
| 701114150 | 14ga x 15cm | In distribution |
| 701116090 | 16ga x 9cm | 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 |
|---|---|
| K252795 | 2026-02-23 |
| K213232 | 2022-07-01 |
Recalls
3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-06-01 | Class I | Material/Component Contamination | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | 1800 | |
| 2026-06-01 | Class I | Material/Component Contamination | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | 680 | |
| 2026-06-01 | Class I | Material/Component Contamination | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. | 850 | |
| 2024-07-02 | Class II | Packaging change control | Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, | 95,430 | |
| 2021-10-04 | Class II | Device Design | Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments. | 79,910 devices | |
| 2019-12-02 | Class II | Labeling Change Control | Incorrect product labeling. | 165 units in U.S. and 330 units Internationally | 2022-11-09 |
| 2017-01-18 | Class II | Equipment maintenance | The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. | 497 boxes | 2017-05-17 |
| 2017-01-18 | Class II | Equipment maintenance | The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. | 772 boxes | 2017-05-17 |
| 2017-01-18 | Class II | Equipment maintenance | The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. | 15 boxes | 2017-05-17 |
| 2015-06-18 | Class II | Packaging process control | Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. | 6390 units | 2016-06-23 |
| 2015-06-18 | Class II | Packaging process control | Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. | 10290 units | 2016-06-23 |
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.