EEA
Black Circular Stapler with Tri-Staple Technology
16manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (3), Shanghai (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Saikang Medical Equipment Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 34 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Jiangsu Yongfa Medical Equipment Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 33 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Zhangjiagang Municipal Cnnc Huakang Radiation Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 17 |
| Changzhou Lookmed Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| B.j.zh.f.panther Medical Equipment Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
| Touchstone International Medical Science Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Victor Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Showing 12 of 16. All 16 manufacturers in China registered for Stapler, Surgical
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | GAG |
| Device type | Stapler, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4740 |
| 510(k) | K192330 |
| Record published | 2020-04-15 |
| Record revised | 2025-06-24 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 3, pack_or_inner_pack of 3 |
| Sizes | Outer diameter 21 to 33 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TRIEEA28XT | Outer Diameter 28 mm | In distribution |
| TRIEEAXL31XT | Outer Diameter 31 mm | In distribution |
| TRIEEA21MT | Outer Diameter 21 mm | In distribution |
| TRIEEAXL21MTORVIL | Outer Diameter 21 mm | In distribution |
| TRIEEA33XT | Outer Diameter 33 mm | In distribution |
| TRIEEAXL33XT | Outer Diameter 33 mm | In distribution |
| TRIEEAXL28XT | Outer Diameter 28 mm | In distribution |
| TRIEEA31XT | Outer Diameter 31 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| McKesson | Mckesson Medical-Surgical Inc. | 23 |
| Medline Industries, Inc. | Medline Industries, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 7 |
| Aeon | Lexington Medical, Inc. | 6 |
| Echelon | Ethicon Endo-Surgery, Inc. | 6 |
| easyEndoTM Lite Linear Cutting Stapler for Single Use | Ezisurg Medical Co., Ltd. | 6 |
| Echelon Linear Cutter | Ethicon Endo-Surgery, Inc. | 5 |
| Henry Schein | Henry Schein, Inc. | 4 |
| Ethicon | Ethicon Endo-Surgery, Inc. | 3 |
| Tri-Staple 2.0 | Covidien LP | 3 |
| GIA | Covidien LP | 3 |
| Medline | Medline Industries, Inc. | 2 |
Showing 12 of 21. All products under Stapler, Surgical
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2018-08-17 | Class II | Process design | The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following applicati | 1,902 | 2020-04-10 |
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.