Signia
Small Diameter Curved Tip Intelligent Reload Vascular/Thin - Long; For use with 8 mm Cannula or larger
16manufacturers in China registered for this device type
19catalogue 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 | 2017-07-24 |
| Record revised | 2026-06-10 (version 17) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 63 to 94 °F |
| Packaging | Case of 6, pack_or_inner_pack of 6 |
| Sizes | Length 30 to 60 mm; outer diameter 8 mm; length 25 cm |
| Distribution end date | 2022-10-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SIGMRET | In distribution | |
| SIGLU60A | Length 60 mm | In distribution |
| SIGADAPTSTND | In distribution | |
| SIGPSHELL | In distribution | |
| SIGCIRSTND | Length 25 cm | In distribution |
| SIGSDS30CTV | Outer Diameter 8 mm | In distribution |
| SIGSDS30CTVT | Outer Diameter 8 mm | In distribution |
| SIGRIG | In distribution | |
| SIGSMRTCHGR | In distribution | |
| SIGSDL45CTVT | Long; | In distribution |
| SIGPHANDLE | In distribution | |
| SIGSBCHGR | In distribution | |
| SIGLU45A | Length 45 mm | In distribution |
| SIGADAPTSHORT | In distribution | |
| SIGPHANDLE-RFB | In distribution | |
| SIGADAPTXL | In distribution | |
| SIGCIRTP | Withdrawn | |
| SIGCIRADAPT | Withdrawn | |
| SIGCIRADAPTXL | 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 |
| 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 |
| Staple, Implantable | Ethicon Endo-Surgery, Inc. | 18 |
Showing 12 of 105. All products under Staple, Implantable
Recalls Naming This Product
21 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2025-09-25 | Class II | Process control | A manufacturing issue could lead to a malformed cover tube press which can lead to internal components’ movement during firing – leading to the potential for uncontrolled motion. | 3263 units | |
| Covidien | 510(k) number | 2025-09-25 | Class II | Process control | A manufacturing issue could lead to a malformed cover tube press which can lead to internal components’ movement during firing – leading to the potential for uncontrolled motion. | 2 units (OUS only) | |
| Covidien | 510(k) number | 2024-02-14 | Class II | Under Investigation by firm | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to | 30 Units | |
| Covidien | 510(k) number | 2024-02-14 | Class II | Under Investigation by firm | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to | 3,023 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 | 2021-03-04 | Class II | Under Investigation by firm | Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, th | 5928 units WW: 4212 US 1716 OUS | 2024-07-12 |
| Covidien | UDI-DI | 2021-03-04 | Class II | Under Investigation by firm | Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, th | 11391 units WW: 5982 US 5409 OUS | 2024-07-12 |
| Covidien | UDI-DI | 2021-03-04 | Class II | Under Investigation by firm | Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, th | 15298 units WW: 9204 US; 6094 OUS | 2024-07-12 |
| 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.