Tri-Staple 2.0
Gray Intelligent Reload;Gray Extra Thin/Vascular Intelligent Reload;For use with Signia (TM) stapling system
16manufacturers in China registered for this device type
42catalogue 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) | K160176 |
| Record published | 2017-05-26 |
| Record revised | 2025-06-24 (version 16) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 63 to 94 °F |
| Packaging | Case of 6, pack_or_inner_pack of 6, case of 12 |
| Sizes | Length 30 to 60 mm; outer diameter 28 to 33 cm; outer diameter 21 to 25 mm |
| Distribution end date | 2026-06-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SIGTRSB45AXT | Length 45 mm | In distribution |
| SIGCIR31MT | Outer Diameter 31 cm | In distribution |
| SIG60CTAVM | Vascular/Medium; | In distribution |
| SIG30AVM | Vascular/Medium; | In distribution |
| SIG60AVM | Length 60 mm | In distribution |
| SIGC45VM | Length 45 mm | In distribution |
| SIG60AXT | Extra Thick; | In distribution |
| SIGTRSB45AMT | Medium/Thick; | In distribution |
| SIGC60VM | Length 60 mm | In distribution |
| SIGCIR28MT | Outer Diameter 28 cm | In distribution |
| SIG60AMT | Length 60 mm | In distribution |
| SIGCIR21MT | Outer Diameter 21 mm | In distribution |
| SIG45CTAVM | Vascular/Medium; | In distribution |
| SIG60CTAMT | Medium/Thick; | In distribution |
| SIG30CTAV | Extra Thin/Vascular; | In distribution |
| SIGC45VT | Length 45 mm | In distribution |
| SIG30CTAVM | Length 30 mm | In distribution |
| SIGTRSB60AXT | Extra/Thick; | In distribution |
| SIG45CTAV | Tri-Staple 2.0; | In distribution |
| SIG30AMT | Length 30 mm | In distribution |
| SIGCIR25MT | Outer Diameter 25 mm | In distribution |
| SIG45AXT | Extra Thick; | In distribution |
| SIG45AMT | Length 45 mm | In distribution |
| SIG45CTAMT | Medium/Thick; | In distribution |
| SIG30AV | Extra Thin/Vascular; | In distribution |
| SIGC45MT | Medium/Thick; | In distribution |
| SIGCIR33MT | Outer Diameter 33 cm | In distribution |
| SIG45AVM | Length 45 mm | In distribution |
| SIGRADMT | Medium/Thick; | In distribution |
| SIGC45V | Extra Thin/Vascular; | In distribution |
| SIG45AV | Length 45 mm | In distribution |
| SIGRADXT | Extra Thick; | In distribution |
| SIGC60MT | Medium/Thick; | In distribution |
| SIGTRSB60AMT | Medium/Thick; | In distribution |
| SIGTRS60AMT | Length 60 mm | Withdrawn |
| SIGC60VT | Vascular/Thin; | Withdrawn |
| SIGTRS45AXT | Extra Thick; | Withdrawn |
| SIGC60V | Length 60 mm | Withdrawn |
| SIGRADVM | Vascular/Medium; | Withdrawn |
| SIGCIRIC | Withdrawn | |
| SIGTRS60AXT | Extra Thick; | Withdrawn |
| SIGTRS45AMT | Length 45 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 |
| 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 |
| Staple, Implantable | Ethicon Endo-Surgery, Inc. | 18 |
Showing 12 of 105. All products under Staple, Implantable
Recalls Naming This Product
16 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 | 2024-04-15 | Class II | Under Investigation by firm | Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery | 1681 units | |
| Covidien | 510(k) number | 2023-01-25 | Class II | Process change control | Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated | 264 US; 5056 OUS | |
| Covidien | 510(k) number | 2021-03-23 | Class II | Nonconforming Material/Component | Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete de-gassing of the steriliza | 222 units | 2024-05-15 |
| Covidien | 510(k) number | 2019-05-17 | Class II | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the pote | 3,113,280 | |
| Covidien | 510(k) number | 2019-05-17 | Class II | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the pote | 3,113,280 | |
| Covidien | 510(k) number | 2019-05-17 | Class II | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the pote | 3,113,280 | |
| Covidien | 510(k) number | 2019-05-17 | Class II | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the pote | 3,113,280 | |
| Covidien | 510(k) number | 2019-05-17 | Class II | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the pote | 3,113,280 | |
| Covidien | 510(k) number | 2019-05-17 | Class II | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the pote | 3,113,280 | |
| Covidien | 510(k) number | 2019-05-17 | Class II | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the pote | 3,113,280 | |
| Covidien | 510(k) number | 2019-05-17 | Class II | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the pote | 3,113,280 | |
| Covidien | 510(k) number | 2019-05-17 | Class II | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the pote | 3,113,280 | |
| Covidien | 510(k) number | 2019-05-17 | Class II | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the pote | 3,113,280 | |
| Covidien | 510(k) number | 2019-05-17 | Class II | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the pote | 3,113,280 | |
| Covidien | 510(k) number | 2019-05-17 | Class II | Process control | The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the pote | 3,113,280 | |
| Covidien | 510(k) number | 2017-12-13 | Class II | Component design/selection | Product reportedly shutting down during use. | 2121 | 2020-04-14 |
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.