easyEndoTM Lite Loading Unit for Single Use
easyEndo Lite loading unit provides titanium staples for the compatible linear cutting stapler. The assembled system places two triple-staggered staple rows and divides tissue along the…
easyEndo Lite loading unit provides titanium staples for the compatible linear cutting stapler. The assembled system places two triple-staggered staple rows and divides tissue along the central line.
Loading-unit staple heights include 2.0, 2.5, 3.5, 3.8 and 4.1 mm for differing tissue thicknesses. The listed green 45 mm unit uses the 4.1 mm staple-height configuration.
Listed Item
Lite Loading Unit, 45mm long, staple height 4.1mm, green
Procedure Scope
The system is intended for transection, resection or creation of anastomoses in open or minimally invasive abdominal, gynecological, thoracic and pediatric surgery. The stapler can be reloaded and fired up to 13 times in a single procedure.
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 | 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) | K210909 |
| Record published | 2021-08-10 |
| Record revised | 2026-02-10 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 5 to 30 °C; Storage environment humidity 10 to 80 % RH |
| Packaging | Paper box of 6, shipping case of 3, color case of 6, traveling box of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N45G | In distribution | |
| N45W | In distribution | |
| N60G | In distribution | |
| N45C | In distribution | |
| N45M | In distribution | |
| N60C | In distribution | |
| N60B | In distribution | |
| N60M | In distribution | |
| N60W | In distribution | |
| N45B | 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 |
|---|---|
| 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.