easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
easyEndo Universal loading units supply the staple configuration for the compatible linear cutting stapler. During firing, the system places three staggered staple rows on either side of a…
easyEndo Universal loading units supply the staple configuration for the compatible linear cutting stapler. During firing, the system places three staggered staple rows on either side of a central tissue-dividing line.
The loading-unit range provides different staple heights for different tissue thicknesses. Universal reload options include 2.5, 3.5, 3.8 and 4.1 mm staple sizes.
Listed Item
Loading Units, 60±2mm Long, 2.5±0.2mm height, white
Stapling and Division
The compatible stapler forms titanium staples as it divides tissue between the two staple lines. Loading units are selected for the tissue and compatible instrument within a single-use surgical workflow. The system family covers laparoscopic and other specified surgical applications.
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) | K172960 |
| Record published | 2025-01-07 |
| Record revised | 2026-02-10 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| 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 | Traveling case of 3, color box of 6, color box, traveling box of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| U12S | In distribution | |
| R45C | In distribution | |
| L60W | In distribution | |
| L60B | In distribution | |
| L60C | In distribution | |
| L60G | In distribution | |
| U12M | In distribution | |
| L45C | In distribution | |
| L45B | In distribution | |
| L45W | In distribution | |
| R30B | In distribution | |
| R60G | In distribution | |
| L45G | In distribution | |
| R30W | In distribution | |
| R45G | In distribution | |
| U12L | In distribution | |
| R60C | In distribution | |
| L30B | In distribution | |
| R45W | In distribution | |
| R60B | In distribution | |
| L30W | In distribution | |
| R60W | In distribution | |
| R45B | 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 |
| Circular Stapler | B.j.zh.f.panther Medical Equipment Co., Ltd. | 23 |
| Endopath | Ethicon Endo-Surgery, Inc. | 22 |
| Signia | Covidien LP | 19 |
| Staple, Implantable | Ethicon Endo-Surgery, Inc. | 18 |
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.