Single Use Circular Stapler
This single use circular stapler creates connections between portions of the alimentary tract. Its applications include end to end, end to side and side to side anastomoses, using a…
This single use circular stapler creates connections between portions of the alimentary tract. Its applications include end to end, end to side and side to side anastomoses, using a circular staple line and an integrated cutting mechanism.
Squeezing the handles forms a double staggered circular row of titanium staples. A circular knife then removes excess tissue within the staple line, creating the opening for the anastomosis.
Size Options
The family is offered in six diameter specifications from 21 to 34 mm, with staple sizes of 4.8 or 5.5 mm. These options belong to the circular stapler configuration; other stapler types within the broader product range have different staple patterns and dimensions.
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Zhangjiagang Municipal Cnnc Huakang Radiation Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 17 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Beijing Biosis Healing Biological Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| B.j.zh.f.panther Medical Equipment Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
| Touchstone International Medical Science Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Sinolinks Medical Innovation, Inc. | Changzhou | Jiangsu | Complaint-file establishment | 5 |
| Victor Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
| Lucky Star Lrradiation Science Co., Ltd. Shanghai | Shanghai | Shanghai | Contract manufacturer | 5 |
| Fengh Medical Co., Ltd. | Jiangyin | Jiangsu | Manufacturer | 4 |
| Medtronic (Shanghai) Medical Technology Co., Ltd. | Min Hang District | Shanghai | Specification developer | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for Staple, Implantable
Record
| Listed by | Golden Stapler Surgical Co., Ltd., China |
|---|---|
| FDA product code | GDW |
| Device type | Staple, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4750 |
| 510(k) | K162707 |
| Record published | 2019-06-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CSA23 | In distribution | |
| CSC23 | In distribution | |
| CSA26 | In distribution | |
| CSA29 | In distribution | |
| CSC29 | In distribution | |
| CSC32 | In distribution | |
| CSC26 | In distribution | |
| CSC34 | In distribution | |
| CSA21 | In distribution | |
| CSB23 | In distribution | |
| CSB26 | In distribution | |
| CSA32 | In distribution | |
| CSB32 | In distribution | |
| CSB21 | In distribution | |
| CSC21 | In distribution | |
| CSA34 | In distribution | |
| CSB29 | In distribution | |
| CSB34 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endo GIA | Covidien LP | 51 |
| Aeon | Lexington Medical, Inc. | 48 |
| Proximate | Ethicon Endo-Surgery, Inc. | 42 |
| Tri-Staple 2.0 | Covidien LP | 42 |
| EEA | Covidien LP | 37 |
| Echelon Endopath | Ethicon Endo-Surgery, Inc. | 33 |
| Reloading Unit for Endo Linear Cutter Stapler | B.j.zh.f.panther Medical Equipment Co., Ltd. | 28 |
| GIA | Covidien LP | 24 |
| easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use | Ezisurg Medical Co., Ltd. | 23 |
| Circular Stapler | B.j.zh.f.panther Medical Equipment Co., Ltd. | 23 |
| Endopath | Ethicon Endo-Surgery, Inc. | 22 |
| Signia | Covidien LP | 19 |
Showing 12 of 105. All products under Staple, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162707 | 2017-07-14 |
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.