SureCore Automatic Disposable Biopsy Needle
The Automatic Disposable Biopsy Needle obtains soft-tissue specimens for pathological examination. It is intended for sites such as the liver, kidney, prostate, spleen, lung, thyroid and…
The Automatic Disposable Biopsy Needle obtains soft-tissue specimens for pathological examination. It is intended for sites such as the liver, kidney, prostate, spleen, lung, thyroid and lymph nodes. It is not intended for bone biopsy and cannot be used under MRI guidance.
After loading and positioning the needle at the target tissue edge, automatic firing advances the inner needle into the lesion. The outer cutting cannula then advances over it, cutting and retaining tissue in the sampling groove. The specimen is removed after the needle is withdrawn.
Listed Item
Automatic Disposable Biopsy Needle
Guidance and Supply
Ultrasound, X-ray or CT equipment can guide puncture and sampling. The hand-operated instrument uses single-hand automatic activation and is supplied sterile following ethylene-oxide sterilization. It is nonpyrogenic and intended for one use.
9manufacturers in China registered for this device type
156catalogue 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 | 2023-06-20 |
| 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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BN-1/161322 | In distribution | |
| BN-1/161011-1 | In distribution | |
| BN-1/162522 | In distribution | |
| BN-1/201822-2 | In distribution | |
| BN-1/162511-2 | In distribution | |
| BN-1/141322-1 | In distribution | |
| BN-1/202011 | In distribution | |
| BN-1/161311-1 | In distribution | |
| BN-1/182022 | In distribution | |
| BN-1/142022 | In distribution | |
| BN-1/181622-2 | In distribution | |
| BN-1/202511 | In distribution | |
| BN-1/181322 | In distribution | |
| BN-1/161022-1 | In distribution | |
| BN-1/181622 | In distribution | |
| BN-1/182011 | In distribution | |
| BN-1/141311-2 | In distribution | |
| BN-1/181622-1 | In distribution | |
| BN-1/201811-1 | In distribution | |
| BN-1/201022 | In distribution | |
| BN-1/122511 | In distribution | |
| BN-1/182011-1 | In distribution | |
| BN-1/161611 | In distribution | |
| BN-1/161322-1 | In distribution | |
| BN-1/201622-1 | In distribution | |
| BN-1/201611 | In distribution | |
| BN-1/141311-1 | In distribution | |
| BN-1/201311-1 | In distribution | |
| BN-1/141322-2 | In distribution | |
| BN-1/162022-2 | In distribution | |
| BN-1/161811-2 | In distribution | |
| BN-1/161322-2 | In distribution | |
| BN-1/182022-2 | In distribution | |
| BN-1/181322-1 | In distribution | |
| BN-1/181811 | In distribution | |
| BN-1/162011-1 | In distribution | |
| BN-1/181311-1 | In distribution | |
| BN-1/162011-2 | In distribution | |
| BN-1/201822-1 | In distribution | |
| BN-1/181822-2 | In distribution | |
| BN-1/201011-1 | In distribution | |
| BN-1/141611-1 | In distribution | |
| BN-1/161811 | In distribution | |
| BN-1/141822 | In distribution | |
| BN-1/142511 | In distribution | |
| BN-1/181022-2 | In distribution | |
| BN-1/181311-2 | In distribution | |
| BN-1/181611 | In distribution | |
| BN-1/201311 | In distribution | |
| BN-1/161022-2 | In distribution | |
| BN-1/162022-1 | In distribution | |
| BN-1/181011-2 | In distribution | |
| BN-1/201011-2 | In distribution | |
| BN-1/161022 | In distribution | |
| BN-1/161622 | In distribution | |
| BN-1/182522-2 | In distribution | |
| BN-1/202511-1 | In distribution | |
| BN-1/122011 | In distribution | |
| BN-1/121822 | In distribution | |
| BN-1/161822-2 | In distribution | |
| BN-1/121611 | In distribution | |
| BN-1/182522 | In distribution | |
| BN-1/201322-1 | In distribution | |
| BN-1/181611-1 | In distribution | |
| BN-1/201322-2 | In distribution | |
| BN-1/121011 | In distribution | |
| BN-1/182511-1 | In distribution | |
| BN-1/141811-1 | In distribution | |
| BN-1/142511-2 | In distribution | |
| BN-1/181022-1 | In distribution | |
| BN-1/121322 | In distribution | |
| BN-1/161622-1 | In distribution | |
| BN-1/202022 | In distribution | |
| BN-1/181611-2 | In distribution | |
| BN-1/162511-1 | In distribution | |
| BN-1/121311 | In distribution | |
| BN-1/161611-2 | In distribution | |
| BN-1/142011-2 | In distribution | |
| BN-1/182522-1 | In distribution | |
| BN-1/201622-2 | In distribution | |
| BN-1/142522-2 | In distribution | |
| BN-1/122022 | In distribution | |
| BN-1/202522-2 | In distribution | |
| BN-1/141022-1 | In distribution | |
| BN-1/181022 | In distribution | |
| BN-1/202511-2 | In distribution | |
| BN-1/141322 | In distribution | |
| BN-1/201022-1 | In distribution | |
| BN-1/161622-2 | In distribution | |
| BN-1/141622-2 | In distribution | |
| BN-1/201811 | In distribution | |
| BN-1/141022 | In distribution | |
| BN-1/141311 | In distribution | |
| BN-1/161611-1 | In distribution | |
| BN-1/202011-2 | In distribution | |
| BN-1/181811-1 | In distribution | |
| BN-1/201311-2 | In distribution | |
| BN-1/141011-2 | In distribution | |
| BN-1/162522-1 | In distribution | |
| BN-1/141622 | In distribution | |
| BN-1/161811-1 | In distribution | |
| BN-1/201622 | In distribution | |
| BN-1/202022-2 | In distribution | |
| BN-1/162011 | In distribution | |
| BN-1/121022 | In distribution | |
| BN-1/181011-1 | In distribution | |
| BN-1/162522-2 | In distribution | |
| BN-1/141822-2 | In distribution | |
| BN-1/201322 | In distribution | |
| BN-1/202011-1 | In distribution | |
| BN-1/141822-1 | In distribution | |
| BN-1/141611 | In distribution | |
| BN-1/201022-2 | In distribution | |
| BN-1/142011 | In distribution | |
| BN-1/181811-2 | In distribution | |
| BN-1/142522-1 | In distribution | |
| BN-1/161311 | In distribution | |
| BN-1/201011 | In distribution | |
| BN-1/181822-1 | In distribution | |
| BN-1/121811 | In distribution | |
| BN-1/142511-1 | In distribution | |
| BN-1/202022-1 | In distribution | |
| BN-1/141022-2 | In distribution | |
| BN-1/182511-2 | In distribution | |
| BN-1/141811 | In distribution | |
| BN-1/141011 | In distribution | |
| BN-1/141622-1 | In distribution | |
| BN-1/181322-2 | In distribution | |
| BN-1/141611-2 | In distribution | |
| BN-1/161011 | In distribution | |
| BN-1/182022-1 | In distribution | |
| BN-1/161822-1 | In distribution | |
| BN-1/201822 | In distribution | |
| BN-1/202522-1 | In distribution | |
| BN-1/201811-2 | In distribution | |
| BN-1/162022 | In distribution | |
| BN-1/142011-1 | In distribution | |
| BN-1/122522 | In distribution | |
| BN-1/201611-2 | In distribution | |
| BN-1/142022-1 | In distribution | |
| BN-1/181011 | In distribution | |
| BN-1/142022-2 | In distribution | |
| BN-1/181311 | In distribution | |
| BN-1/201611-1 | In distribution | |
| BN-1/141811-2 | In distribution | |
| BN-1/181822 | In distribution | |
| BN-1/162511 | In distribution | |
| BN-1/121622 | In distribution | |
| BN-1/182511 | In distribution | |
| BN-1/141011-1 | In distribution | |
| BN-1/142522 | In distribution | |
| BN-1/161311-2 | In distribution | |
| BN-1/202522 | In distribution | |
| BN-1/161822 | In distribution | |
| BN-1/161011-2 | In distribution | |
| BN-1/182011-2 | 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 |
| 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.