easyCSTM Circular Stapler for Single Use

The easyCS Circular Stapler for Single Use creates a circular surgical join by placing two staggered rows of titanium staples. Firmly squeezing its handles forms the staples, after which a…

Registry build 21.09.26

The easyCS Circular Stapler for Single Use creates a circular surgical join by placing two staggered rows of titanium staples. Firmly squeezing its handles forms the staples, after which a circular knife removes excess tissue within the staple ring.

The device is offered in several circular sizes to match the intended join. Staple heights of 3.5 mm and 4.8 mm accommodate different tissue thicknesses. The circular stapling and cutting mechanism acts together to create the anastomosis.

Listed Item

Circular Stapler, 21.5mm long, staple height 3.5mm, Sky blue

Single-Use Configuration

The circular stapler is a single-use instrument. Its circular knife and staple ring differ from the straight cutting path and reloadable staple rows of linear staplers.

16manufacturers in China registered for this device type
8catalogue numbers in this listing
5510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code GDW
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

Regulatory record for easyCSTM Circular Stapler for Single Use
Listed by Ezisurg Medical Co., Ltd., China
FDA product code GDW
Device type Staple, Implantable
Device class Class 2
Regulation 21 CFR 878.4750
Establishment Manufacturer
510(k) K181657
Record published 2025-01-07
Record revised 2026-02-10 (version 2)

Specifications

Specifications
MRI safety MR Conditional
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment humidity 10 to 80 % RH; Storage environment temperature 5 to 30 °C
Packaging Color box, traveling case of 4

Catalogue Numbers

Catalogue numbers for easyCSTM Circular Stapler for Single Use
Catalogue number Size Status
CS2535 In distribution
CS2148 In distribution
CS3348 In distribution
CS3148 In distribution
CS2548 In distribution
CS2935 In distribution
CS2135 In distribution
CS2948 In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance Decision date
K210909 2021-06-24
K183477 2019-02-11
K181657 2019-02-01
K172960 2017-12-21
K143129 2015-01-29

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer