GIA
Black Extra Thick Stapler with Tri-Staple Technology
16manufacturers in China registered for this device type
24catalogue 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) | K111825 |
| Record published | 2015-09-01 |
| Record revised | 2025-06-24 (version 14) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature up to 130 °F |
| Packaging | Case of 3, case of 6, pack_or_inner_pack of 6 |
| Sizes | Length 60 to 100 mm; height 2.5 to 4.8 mm |
| Distribution end date | 2025-11-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GIA8038L | Length 80 mm | In distribution |
| GIA80XTS | Length 80 mm | In distribution |
| GIA6025S | Length 60 mm | In distribution |
| GIA80XTC | Length 80 mm | In distribution |
| GIA60XTS | Length 60 mm | In distribution |
| GIA8038S | Length 80 mm | In distribution |
| GIA6048L | Length 60 mm | In distribution |
| GIA6038S | Length 60 mm | In distribution |
| GIA10038S | Height 3.8 mm | In distribution |
| GIA8048S | Height 4.8 mm | In distribution |
| GIA6038L | Height 3.8 mm | In distribution |
| GIA6048S | Height 4.8 mm | In distribution |
| GIA10038L | Length 100 mm | In distribution |
| GIA8048L | Length 80 mm | In distribution |
| GIA80TMC | Length 80 mm | In distribution |
| GIA60MTC | Length 60 mm | In distribution |
| GIA10048L | Height 4.8 mm | In distribution |
| GIA6025L | Height 2.5 mm | In distribution |
| GIA60XTC | Length 60 mm | In distribution |
| GIA10048S | Length 100 mm | In distribution |
| GIA60MTS | Length 60 mm | In distribution |
| GIA80MTS | Length 80 mm | In distribution |
| GIA80MTC | Length 80 mm | In distribution |
| 030403 | 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 |
| 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
73 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 | 2020-11-23 | Class II | Process control | May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue da | 3255 units US; 3574 units OUS | |
| Covidien | 510(k) number | 2020-11-23 | Class II | Process control | May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue da | 5316 units US; 1209 units OUS | |
| Covidien | 510(k) number | 2020-08-12 | Class II | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. | 900,007 total | |
| Covidien | 510(k) number | 2020-08-12 | Class II | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. | 900,007 total | |
| Covidien | 510(k) number | 2020-08-12 | Class II | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. | 900,007 total | |
| Covidien | 510(k) number | 2020-08-12 | Class II | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. | 900,007 total | |
| Covidien | 510(k) number | 2020-08-12 | Class II | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. | 900,007 total | |
| Covidien | 510(k) number | 2020-08-12 | Class II | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. | 900,007 total | |
| Covidien | 510(k) number | 2020-08-12 | Class II | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. | 900,007 total | |
| Covidien | 510(k) number | 2020-08-12 | Class II | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. | 900,007 total | |
| Covidien | 510(k) number | 2020-08-12 | Class II | Under Investigation by firm | The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation. | 900,007 total | |
| Covidien | 510(k) number | 2020-01-17 | Class II | Package design/selection | Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection | 2,180 units | 2022-07-29 |
| 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 | 2018-05-22 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | ||
| Covidien | 510(k) number | 2018-05-22 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | ||
| Covidien | 510(k) number | 2018-05-22 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | ||
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
| Covidien | 510(k) number | 2018-04-26 | Class II | Process control | Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents. | 171,271 units in total | 2020-06-17 |
Showing 40 of 73.
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.