EEA
Black Extra Thick XL Circular Stapler with Tri-Staple Technology
16manufacturers in China registered for this device type
37catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | GDW |
| Device type | Staple, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4750 |
| 510(k) | K221771 |
| Record published | 2024-05-03 |
| Record revised | 2025-06-24 (version 13) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature up to 130 °F |
| Packaging | Case of 3, pack_or_inner_pack of 3, case of 6 |
| Sizes | Outer diameter 21 to 33 mm; height 3.5 to 4.8 mm; length 21 to 28 mm; width 25 mm |
| Distribution end date | 2026-03-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TRIEEA21XT | Outer Diameter 21 mm | In distribution |
| TRIEEAXL33MT | Outer Diameter 33 mm | In distribution |
| TRIEEAXL21XTORVIL | Outer Diameter 21 mm | In distribution |
| EEAXL31 | Length,XL,N/A; | In distribution |
| EEAXL2835 | Outer Diameter 28 mm | In distribution |
| TRIEEA25MT | Width 25 mm | In distribution |
| TRIEEA31MT | Medium/Thick; | In distribution |
| TRIEEAXL21MT | Outer Diameter 21 mm | In distribution |
| TRIEEA28MT | Medium/Thick; | In distribution |
| TRIEEAXL25MTORVIL | 25mm; | In distribution |
| TRIEEAXL28MT | Outer Diameter 28 mm | In distribution |
| TRIEEA33MT | Outer Diameter 33 mm | In distribution |
| EEAXL2535 | Outer Diameter 25 mm | In distribution |
| EEA2535 | Length 25 mm | In distribution |
| EEA33 | Outer Diameter 33 mm | In distribution |
| EEAXL21 | Height 4.8 mm | In distribution |
| EEAXL33 | Length,XL,N/A; | In distribution |
| TRIEEA25XT | Width 25 mm | In distribution |
| HEM3335 | Height 3.5 mm | In distribution |
| EEAXL28 | Height 4.8 mm | In distribution |
| EEA25 | Length 25 mm | In distribution |
| EEA28 | Length 28 mm | In distribution |
| TRIEEAXL25XT | Width 25 mm | In distribution |
| TRIEEAXL25XTORVIL | 25mm; | In distribution |
| TRIEEAXL31MT | Outer Diameter 31 mm | In distribution |
| TRIEEAXL21XT | Outer Diameter 21 mm | In distribution |
| EEA2135 | Height 3.5 mm | In distribution |
| EEA21 | Length 21 mm | In distribution |
| EEA31 | Height 4.8 mm | In distribution |
| TRIEEAXL25MT | Width 25 mm | In distribution |
| EEAXL2135 | Outer Diameter 21 mm | In distribution |
| EEA2835 | Height 3.5 mm | In distribution |
| EEAXL25 | Height 4.8 mm | In distribution |
| 110276L | Outer Diameter 31 mm | Withdrawn |
| HEM3348 | Outer Diameter 33 mm | Withdrawn |
| 110238L | Outer Diameter 28 mm | Withdrawn |
| 110214L | Outer Diameter 25 mm | Withdrawn |
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 |
| 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 |
| Staple, Implantable | Ethicon Endo-Surgery, Inc. | 18 |
Showing 12 of 105. All products under Staple, Implantable
Recalls Naming This Product
3 recalls name this product by its own identifiers, 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 |
| Covidien | 510(k) number | 2018-04-09 | Class II | Nonconforming Material/Component | There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak. | 5547 | 2020-05-12 |
| Covidien | 510(k) number | 2018-04-09 | Class II | Nonconforming Material/Component | There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak. | 475 | 2020-05-12 |
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.