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Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single P…
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
510(k) K162707Ref NKTL10Ref LSC45GRef LCA75BRef K55LNKTRef CSB23Ref LSC45YRef TPTL12Ref CSL10Ref LCAR75GRef K512LNKTRef CSL11Ref CSB29Ref LSCR45BRef LSC30WRef K11LNKTRef K511LNKTRef CSA26Ref CSB32Ref LCAR75YRef NKTL11Ref PPHD32Ref CCSA40GRef CCZB40GRef LSC30GRef TPTL5Ref K12LNKTRef CSA32Ref SSA35WRef LCAR75BRef CSL5Ref CCZBR40GRef LCA75YRef LCA55GRef LSCR60GRef K10LNKTRef LSC30B Ref LSCR30B Ref LSC60GRef LSC45BRef LCA100BRef CSB21Ref PPHD36Ref LSCR30GRef CSA23Ref CSA21Ref LCAR100GRef NKTL12Ref LCA100GRef LCAR100YRef CSA29
Identity
- Trade Name
- Golden Stapler EUDAMEDSingle Use Circular Stapler FDA UDI
- Generic Name
- Intraluminal circular stapler, single-use FDA UDI
- Device Name
- Single Use Abdominal Trocar EUDAMEDSingle Patient Use Linear Stapler and Reload EUDAMEDSingle Patient Use Linear Cutter and Reload EUDAMEDSingle Use Circular Stapler EUDAMEDSingle Use Hemorrhoidal Circular Stapler EUDAMEDSingle Patient Use Transverse Cutter and Reload EUDAMEDSingle Patient Use Skin Stapler EUDAMED
- Model / Reference
- CSA26 EUDAMEDFDA UDICSB32 EUDAMEDFDA UDICSB23 EUDAMEDFDA UDICSA29 EUDAMEDFDA UDICSA23 EUDAMEDFDA UDICSB29 EUDAMEDFDA UDICSB21 EUDAMEDFDA UDICSA21 EUDAMEDFDA UDICSA32 EUDAMEDFDA UDINKTL10 EUDAMEDLSC45G EUDAMEDLCA75B EUDAMEDK55LNKT EUDAMEDLSC45Y EUDAMEDTPTL12 EUDAMEDCSL10 EUDAMEDLCAR75G EUDAMEDK512LNKT EUDAMEDCSL11 EUDAMEDLSCR45B EUDAMEDLSC30W EUDAMEDK11LNKT EUDAMEDK511LNKT EUDAMEDLCAR75Y EUDAMEDNKTL11 EUDAMEDPPHD32 EUDAMEDCCSA40G EUDAMEDCCZB40G EUDAMEDLSC30G EUDAMEDTPTL5 EUDAMEDK12LNKT EUDAMEDSSA35W EUDAMEDLCAR75B EUDAMEDCSL5 EUDAMEDCCZBR40G EUDAMEDLCA75Y EUDAMEDLCA55G EUDAMEDLSCR60G EUDAMEDK10LNKT EUDAMEDLSC30B EUDAMEDLSCR30B EUDAMEDLSC60G EUDAMEDLSC45B EUDAMEDLCA100B EUDAMEDPPHD36 EUDAMEDLSCR30G EUDAMEDLCAR100G EUDAMEDNKTL12 EUDAMEDLCA100G EUDAMEDLCAR100Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946912215030 EUDAMEDFDA UDI06946912216051 EUDAMEDFDA UDI06946912216020 EUDAMEDFDA UDI06946912215047 EUDAMEDFDA UDI06946912215023 EUDAMEDFDA UDI06946912216044 EUDAMEDFDA UDI06946912216013 EUDAMEDFDA UDI06946912215016 EUDAMEDFDA UDI06946912215054 EUDAMEDFDA UDI06946912245082 EUDAMED06946912237063 EUDAMED06946912278059 EUDAMED06946912249141 EUDAMED06946912237056 EUDAMED06946912248144 EUDAMED06946912255043 EUDAMED06946912279070 EUDAMED06946912249011 EUDAMED06946912255074 EUDAMED06946912239043 EUDAMED06946912237018 EUDAMED06946912249202 EUDAMED06946912249172 EUDAMED06946912279063 EUDAMED06946912245112 EUDAMED06946912225138 EUDAMED06946912213166 EUDAMED06946912213074 EUDAMED06946912237032 EUDAMED06946912248021 EUDAMED06946912249028 EUDAMED06946912295025 EUDAMED06946912279056 EUDAMED06946912255012 EUDAMED06946912214071 EUDAMED06946912278066 EUDAMED06946912278042 EUDAMED06946912239098 EUDAMED06946912249196 EUDAMED06946912237025 EUDAMED06946912239029 EUDAMED06946912237094 EUDAMED06946912237049 EUDAMED06946912278080 EUDAMED06946912225282 EUDAMED06946912239036 EUDAMED06946912279100 EUDAMED06946912245143 EUDAMED06946912278103 EUDAMED06946912279094 EUDAMED
- Basic UDI-DI
- B-06946912245082 EUDAMEDB-06946912237063 EUDAMEDB-06946912278059 EUDAMEDB-06946912249141 EUDAMEDB-06946912216020 EUDAMEDB-06946912237056 EUDAMEDB-06946912248144 EUDAMEDB-06946912255043 EUDAMEDB-06946912279070 EUDAMEDB-06946912249011 EUDAMEDB-06946912255074 EUDAMEDB-06946912216044 EUDAMEDB-06946912239043 EUDAMEDB-06946912237018 EUDAMEDB-06946912249202 EUDAMEDB-06946912249172 EUDAMEDB-06946912215030 EUDAMEDB-06946912216051 EUDAMEDB-06946912279063 EUDAMEDB-06946912245112 EUDAMEDB-06946912225138 EUDAMEDB-06946912213166 EUDAMEDB-06946912213074 EUDAMEDB-06946912237032 EUDAMEDB-06946912248021 EUDAMEDB-06946912249028 EUDAMEDB-06946912215054 EUDAMEDB-06946912295025 EUDAMEDB-06946912279056 EUDAMEDB-06946912255012 EUDAMEDB-06946912214071 EUDAMEDB-06946912278066 EUDAMEDB-06946912278042 EUDAMEDB-06946912239098 EUDAMEDB-06946912249196 EUDAMEDB-06946912237025 EUDAMEDB-06946912239029 EUDAMEDB-06946912237094 EUDAMEDB-06946912237049 EUDAMEDB-06946912278080 EUDAMEDB-06946912216013 EUDAMEDB-06946912225282 EUDAMEDB-06946912239036 EUDAMEDB-06946912215023 EUDAMEDB-06946912215016 EUDAMEDB-06946912279100 EUDAMEDB-06946912245143 EUDAMEDB-06946912278103 EUDAMEDB-06946912279094 EUDAMEDB-06946912215047 EUDAMED
- 510(k) Number
- FDA Product Code
- GDW FDA 510(k)FDA UDI
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMEDH020201020102 SINGLE-USE ARTICULATED LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMEDH020201010101 SINGLE PATIENT STRAIGHT LINEAR STAPLERS WITH BLADE FOR OPEN SURGERY EUDAMEDH0202020201 SINGLE-USE CURVED CIRCULAR STAPLERS FOR OPEN SURGERY EUDAMEDH020401 SINGLE PATIENT TRANSANAL RECTAL STAPLERS EUDAMEDH02010102 SKIN STAPLERS, SINGLE PATIENT EUDAMED
- GMDN Term
- Intraluminal circular stapler, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4750 FDA 510(k)
- Regulation Number
- 878.4750 FDA 510(k)FDA UDI
- Market of Registration
- Greece EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
The device includes single use circular staplers, single use hemorrhoidal circular staplers, and single patient use linear staplers, reloads, cutters, and transverse cutters. These devices are designed for surgical procedures including hemorrhoidal treatment, reconstruction of the digestive tract, and creation of anastomoses.
The devices are single use and intended for transection, closure of stumps, and creation of anastomoses in various surgical applications. They are authorized under FDA 510K and MDD regulations, with product code GDW, and are manufactured by Golden Stapler Surgical Co., Ltd.
Frequently asked questions
What are the primary uses of these stapler devices?
These devices are designed for surgical procedures including hemorrhoidal treatment, reconstruction of the digestive tract, and creation of anastomoses. They are used for transection, closure of stumps, and creating anastomoses in various surgical applications.
Are these devices single-use or reusable?
These devices are single-use and intended for single patient use only. They should not be reused on multiple patients as they are designed for one-time use in surgical procedures.
What types of staplers are included in this device category?
The device category includes single use circular staplers, single use hemorrhoidal circular staplers, and single patient use linear staplers, reloads, cutters, and transverse cutters for various surgical applications.
What regulatory authorizations do these devices have?
These devices are authorized under FDA 510K and MDD regulations. They have product code GDW and are manufactured by Golden Stapler Surgical Co., Ltd.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Single Use Hemorrhoidal Circular Stapler - Golden Stapler, Open Products - Golden Stapler Surgical Co., Ltd., Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler ..., Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler ...
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDD
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162707 | Class II | Active |
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Manufacturer
- Manufacturer
- Golden Stapler Surgical Co., Ltd
- FDA Applicant
- Golden Stapler Surgical Co., Ltd.
Sources (60)
- FDA 510(k) K162707 24 fields · synced Sep 18, 2026
- FDA UDI af3ee7ff-4b1a-42b3-ba2f-0e647083918c 33 fields · synced May 29, 2026
- FDA UDI a19d182c-3397-4c6a-985d-3ef50af035ff 33 fields · synced May 30, 2026
- FDA UDI c02c2613-128d-4ebf-b62f-9f408f43e78c 33 fields · synced May 30, 2026
- FDA UDI 2976995d-ad34-4235-8602-8ff5b486233d 33 fields · synced May 30, 2026
- FDA UDI 4d0bccbe-8424-4ba5-8ae3-b5cb6bff9804 33 fields · synced May 30, 2026
- FDA UDI bc7fa269-59eb-4135-9777-901bd521495c 33 fields · synced May 30, 2026
- FDA UDI b9be0b70-27ee-44ed-bb19-6c73df0fa32c 33 fields · synced May 30, 2026
- FDA UDI 39730ffd-eb2c-40ca-a154-15934c1dcc99 33 fields · synced May 30, 2026
- FDA UDI 58c2bc83-11f9-421c-952c-b86db48b4ff4 33 fields · synced May 30, 2026
- EUDAMED cab7d4de-02e2-4cc0-a2f6-96cd9023e29b 61 fields · synced Jul 8, 2026
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- EUDAMED 458c454d-45d9-4164-9251-451b9f9e554c 61 fields · synced Jul 10, 2026
- EUDAMED 2d6467fc-ed10-4338-9d18-8f0f1ee42e4a 61 fields · synced Jul 10, 2026
- EUDAMED e3976db8-1b34-4e26-be3a-395e990452fe 61 fields · synced Jul 11, 2026
- EUDAMED 294f2fc4-b10c-4567-a6e3-820365b63f69 61 fields · synced Jul 11, 2026
- EUDAMED a18e7228-f8ea-441b-8fcf-9193ee04ba35 61 fields · synced Jul 11, 2026
- EUDAMED 6426c5bc-c1bb-45aa-8116-eae30cdce5fd 61 fields · synced Jul 11, 2026
- EUDAMED 72037ff7-d89c-4d16-860c-689bd8c1ee3b 61 fields · synced Jul 12, 2026
- EUDAMED b9db7f02-f9bc-4461-89b5-10980132783c 61 fields · synced Jul 12, 2026
- EUDAMED 8e2e18bd-1bda-4aeb-a2aa-e3dd053db272 61 fields · synced Jul 13, 2026
- EUDAMED c8086881-e0ac-4451-a3b8-44c1e514d62b 61 fields · synced Jul 13, 2026
- EUDAMED dc170297-5773-4106-866f-ca48947dcb35 61 fields · synced Jul 13, 2026
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- EUDAMED 34d31524-93cd-4141-9598-8908d0ea9ce1 61 fields · synced Jul 15, 2026
- EUDAMED 691855e6-b137-4928-8ea8-2a89bae2c1c6 61 fields · synced Jul 15, 2026
- EUDAMED cde0510a-d32b-4184-b0b9-d7bbef9d08a6 61 fields · synced Jul 15, 2026
- EUDAMED 3cb124e7-bf94-49bc-b82d-af74b1e2dff2 61 fields · synced Jul 15, 2026
- EUDAMED 5260d88e-3b3b-4e64-be9f-67e8067ff7b4 61 fields · synced Jul 15, 2026
- EUDAMED c4d7bdb2-0dce-4767-bba3-e56341784767 61 fields · synced Jul 16, 2026
- EUDAMED cfdbb329-b9e5-467a-bb1b-e48fb34a081f 61 fields · synced Jul 16, 2026
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- EUDAMED f9016412-a655-4006-89b5-804e343c6846 61 fields · synced Jul 21, 2026
- EUDAMED 0cebf1d0-a0b3-41f8-a021-225da2677a71 61 fields · synced Jul 21, 2026
- EUDAMED cfaad20b-cd9a-4813-8a5d-3d81a8ab7fc5 61 fields · synced Jul 22, 2026
- EUDAMED 716a52ee-1ecb-4154-8fc2-ce8e752010b5 61 fields · synced Jul 23, 2026
- EUDAMED 757e89e5-f207-408e-8f5d-5b1b47fe45e2 61 fields · synced Jul 24, 2026
- EUDAMED 33bc25c7-4ec1-463c-ba1a-efb11f82ba7a 61 fields · synced Jul 24, 2026
- EUDAMED f710c92d-4c88-4348-b70f-620da1a2fdde 61 fields · synced Jul 24, 2026
- EUDAMED 8e91cc5d-4431-4fc1-9318-a20daa366a94 61 fields · synced Jul 25, 2026
- EUDAMED b6468471-59ea-4138-a382-4325d6d6a9ea 61 fields · synced Jul 27, 2026
- EUDAMED 2e1d27dd-e49c-42f3-9d13-1d87fedced30 61 fields · synced Jul 28, 2026
- EUDAMED 0655ae74-ae33-4ac3-a74d-52dbeb03560c 61 fields · synced Jul 29, 2026
- EUDAMED 2be023b5-1fce-4546-a6b1-a0e981c5c938 61 fields · synced Jul 30, 2026
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- EUDAMED 5f21a883-7686-4963-a7a6-6d6b1f35b438 61 fields · synced Aug 1, 2026
- EUDAMED e5d1246a-f407-4062-a631-e2bcb74ca437 61 fields · synced Aug 2, 2026
- EUDAMED 662d1854-ca07-4aed-956b-360069b93136 61 fields · synced Aug 4, 2026
- EUDAMED 3e88543e-9c46-484f-aa9d-80ff0c6fb272 61 fields · synced Aug 4, 2026
- EUDAMED 1e3e9694-c144-4d9b-a39a-b7d62bccb8df 61 fields · synced Sep 18, 2026