Cassi
The Cassi Rotational Core Biopsy System with Quadpoint Disposable is used to perform biopsy pro-cedures on multiple patients. Up to 7 biopsy cycles (1 mandatory pre-test and 6 biopsies) can…
The Cassi Rotational Core Biopsy System with Quadpoint Disposable is used to perform biopsy pro-cedures on multiple patients. Up to 7 biopsy cycles (1 mandatory pre-test and 6 biopsies) can be performed per patient. The Cassi system components and catalog numbers are: REF: CS2100-NT Cassi Rotational Core Biopsy Needle → 10 gauge 10 → Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with 10 gauge cutting cannula with trocar REF: CS2120-NT Cassi Rotational Core Biopsy Needle → 12 gauge 10 → Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with a 12 gauge cutting cannula with trocar REF: CS2001-CC-10 10 → Non-sterile single-use CO2 (carbon dioxide) canisters with caps REF:CS2001-BH 1 → Non-sterile limited reusable biopsy handle and 1 spare limited-use 9 → volt alkaline battery
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 | Scion Medical Techologies, LLC |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Record published | 2016-09-30 |
| Record revised | 2021-03-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS2120-NT-1 | In distribution | |
| CS2100-NT-1 | In distribution | |
| CS-2001-CC-10 | In distribution | |
| CS2001-BH | 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
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.