Semi-Automatic Biopsy-Needle BIM 16/20
Catalogue number BIM 16/20, listed by Itp Innovative Tomography Products GmbH, Germany, under Instrument, Biopsy. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
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 | Itp Innovative Tomography Products GmbH, Germany |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Record published | 2023-02-16 |
| Record revised | 2024-04-09 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 50 °C |
| Packaging | Box of 10 |
| Sizes | Length 200 mm; needle gauge 16 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BIM 16/20 | Length 200 mm | 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 |
|---|---|
| K233294 | 2024-06-18 |
| K222462 | 2023-01-20 |
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.