M-Biopsy
Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by cutting from lung, liver, spleen,…
Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by cutting from lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and pancreas, for microscopic examination. When used for breast biopsy, the product is for diagnosis only.
9manufacturers in China registered for this device type
58catalogue numbers in this listing
1510(k) clearance
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 | Mermaid Medical A/S, Denmark |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2026-03-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight and keep dry; Handling environment temperature -29 to 60 °C |
| Packaging | Retail box of 10 |
| Sizes | Length 6 to 30 cm; needle gauge 14 to 20 G |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N30114006 | Length 6 cm | Withdrawn |
| N30216020 | Coaxial Introducer Needle | Withdrawn |
| NS3012016 | Kit | Withdrawn |
| N30116010 | Length 10 cm | Withdrawn |
| N30114020 | Length 20 cm | Withdrawn |
| N30118025 | Length 25 cm | Withdrawn |
| NS3012020 | Kit | Withdrawn |
| NS3011820 | Kit | Withdrawn |
| NS3011620 | Kit | Withdrawn |
| N30118006 | Length 6 cm | Withdrawn |
| N30114012 | Length 12 cm | Withdrawn |
| N30216008 | Coaxial Introducer Needle | Withdrawn |
| N30214008 | Coaxial Introducer Needle | Withdrawn |
| N30120016 | Length 16 cm | Withdrawn |
| NS3011416 | Length 16 cm | Withdrawn |
| N30118030 | Length 30 cm | Withdrawn |
| N30116025 | Length 25 cm | Withdrawn |
| N30220008 | Coaxial Introducer Needle | Withdrawn |
| N30118008 | Length 8 cm | Withdrawn |
| N30218020 | Coaxial Introducer Needle | Withdrawn |
| N30118012 | Length 12 cm | Withdrawn |
| N30220010 | Coaxial Introducer Needle | Withdrawn |
| N30220020 | Coaxial Introducer Needle | Withdrawn |
| N30218010 | Coaxial Introducer Needle | Withdrawn |
| NS3011816 | Kit | Withdrawn |
| NS3011420 | Kit | Withdrawn |
| N30114025 | Length 25 cm | Withdrawn |
| N30116012 | Length 12 cm | Withdrawn |
| N30120012 | Length 12 cm | Withdrawn |
| NS3011810 | Kit | Withdrawn |
| N30214020 | Coaxial Introducer Needle | Withdrawn |
| NS3011410 | Kit | Withdrawn |
| N30116006 | Length 6 cm | Withdrawn |
| N30114016 | Length 16 cm | Withdrawn |
| N30214016 | Coaxial Introducer Needle | Withdrawn |
| N30218008 | Coaxial Introducer Needle | Withdrawn |
| NS3011616 | Kit | Withdrawn |
| N30120006 | Length 6 cm | Withdrawn |
| N30220012 | Coaxial Introducer Needle | Withdrawn |
| N30116008 | Length 8 cm | Withdrawn |
| NS3011610 | Kit | Withdrawn |
| N30120010 | Length 10 cm | Withdrawn |
| N30120020 | Length 20 cm | Withdrawn |
| N30216010 | Coaxial Introducer Needle | Withdrawn |
| NS3012010 | Kit | Withdrawn |
| N30118020 | Length 20 cm | Withdrawn |
| N30220016 | Coaxial Introducer Needle | Withdrawn |
| N30218016 | Coaxial Introducer Needle | Withdrawn |
| N30218012 | Coaxial Introducer Needle | Withdrawn |
| N30214010 | Coaxial Introducer Needle | Withdrawn |
| N30216016 | Coaxial Introducer Needle | Withdrawn |
| N30114010 | Length 10 cm | Withdrawn |
| N30118016 | Length 16 cm | Withdrawn |
| N30118010 | Length 10 cm | Withdrawn |
| N30120008 | Length 8 cm | Withdrawn |
| N30114008 | Length 8 cm | Withdrawn |
| N30116020 | Length 20 cm | Withdrawn |
| N30116016 | Length 16 cm | Withdrawn |
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 |
|---|---|
| K161409 | 2016-08-02 |
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.