Invivo
MRI/Conv. Fully Automatic Biopsy Set
9manufacturers in China registered for this device type
71catalogue numbers in this listing
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 | Philips DS North America LLC, United States |
|---|---|
| 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) | K981320 |
| Record published | 2016-09-23 |
| Record revised | 2025-09-29 (version 12) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity 30 to 75 % RH; Storage environment temperature 15 to 30 °C |
| Sizes | Needle gauge 12 to 22 G; length 50 to 270 mm; outer diameter 1 to 4.1 mm |
| Distribution end date | 2023-09-29 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 98960320340 | Length 61 mm | In distribution |
| 98960321021 | Outer Diameter 4.1 mm | In distribution |
| 98960320368 | In distribution | |
| 98960320313 | Needle Gauge 18 G | In distribution |
| 98960320413 | Length 150 mm | In distribution |
| 98960321022 | Outer Diameter 1 mm | In distribution |
| 98960320757 | Needle Gauge 16 G | In distribution |
| 98960320320 | Needle Gauge 22 G | In distribution |
| 98960321019 | Outer Diameter 3 mm | In distribution |
| 98960320286 | Length 150 mm | In distribution |
| 98960320282 | Length 150 mm | In distribution |
| Needle Block, 14G | Needle Gauge 14 G | In distribution |
| 98960321015 | Outer Diameter 4 mm | In distribution |
| 98960320446 | In distribution | |
| 98960320905 | Length 130 mm | In distribution |
| 98960320337 | Length 111 mm | In distribution |
| 98960321014 | Outer Diameter 4 mm | In distribution |
| 98960320304 | Needle Gauge 14 G | In distribution |
| Needle Sleeve 14G | Needle Gauge 14 G | In distribution |
| 98960320316 | Needle Gauge 20 G | In distribution |
| 98960320369 | In distribution | |
| 98960320756 | Length 150 mm | In distribution |
| 98960320284 | Length 150 mm | In distribution |
| 98960320369 | In distribution | |
| Needle Block, 16G | Needle Gauge 16 G | In distribution |
| 98960321012 | Outer Diameter 4 mm | In distribution |
| 98960320307 | Length 150 mm | In distribution |
| 98960320305 | Needle Gauge 16 G | In distribution |
| 98960321024 | Outer Diameter 4 mm | In distribution |
| 98960320300 | Needle Gauge 12 G | In distribution |
| 98960321010 | Needle Gauge 16 G | In distribution |
| 98960321018 | Outer Diameter 3 mm | In distribution |
| 98960321016 | Outer Diameter 3 mm | In distribution |
| 98960320339 | Length 111 mm | In distribution |
| 98960320374 | In distribution | |
| 98960320321 | Length 100 mm | In distribution |
| 98960320371 | In distribution | |
| 9896032065 | Needle Gauge 16 G | In distribution |
| 98960320333 | Needle Gauge 18 G | In distribution |
| 98960320299 | Length 115 mm | In distribution |
| 98960321023 | Outer Diameter 3 mm | In distribution |
| 98960320373 | In distribution | |
| 98960320288 | Length 130 mm | In distribution |
| 98960320375 | In distribution | |
| 98960320412 | Needle Gauge 12 G | In distribution |
| 98960320890 | Needle Gauge 14 G | In distribution |
| 98960320334 | Length 61 mm | In distribution |
| 98960320335 | Length 130 mm | In distribution |
| Needle Sleeve 18G | Needle Gauge 18 G | In distribution |
| 98960321020 | Length 170 mm | In distribution |
| 98960320370 | In distribution | |
| 98960320281 | Needle Gauge 14 G | In distribution |
| 98960320649 | Needle Gauge 12 G | In distribution |
| 98960321013 | Outer Diameter 4 mm | In distribution |
| 98960320276 | Needle Gauge 20 G | In distribution |
| 98960321017 | Outer Diameter 3 mm | In distribution |
| 98960320319 | Needle Gauge 20 G | In distribution |
| 98960320336 | Needle Gauge 12 G | In distribution |
| 98960320341 | Length 111 mm | In distribution |
| 98960320338 | Needle Gauge 14 G | In distribution |
| 15144 | Outer Diameter 4.1 mm | In distribution |
| 98960320365 | In distribution | |
| 98960321011 | Length 111 mm | In distribution |
| 15142 | Length 170 mm | Withdrawn |
| 98960320298 | Needle Gauge 18 G | Withdrawn |
| 98960320301 | Length 115 mm | Withdrawn |
| 98960320879 | Needle Gauge 18 G | Withdrawn |
| 98960320295 | Needle Gauge 14 G | Withdrawn |
| 98960320878 | Length 175 mm | Withdrawn |
| 98960320528 | Needle Gauge 18 G | Withdrawn |
| 98960320302 | Length 150 mm | 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 |
| 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
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.