Question 1

What types of medical devices does Golden Stapler Surgical Co., Ltd primarily manufacture?

Accepted Answer

Golden Stapler Surgical Co., Ltd specializes in single-use surgical staplers, focusing on intraluminal circular staplers for anastomosis (joining tissues) and linear staplers for tissue resection. Their portfolio includes devices like circular staplers, reloadable linear cutters, hemorrhoidal staplers, and powered endoscopic cutters. These are designed for minimally invasive procedures in gastrointestinal and colorectal surgeries.

Question 2

Where is Golden Stapler Surgical Co., Ltd based, and how does this affect its regulatory compliance?

Accepted Answer

Golden Stapler Surgical Co., Ltd is based in China. Since its devices are marketed in regions like the EU and the US, the company must comply with local regulatory requirements, such as EUDAMED listings for the EU and FDA registrations (including 510(k) submissions and UDI entries) for the US. Compliance ensures these devices meet safety, performance, and quality standards before authorization.

Question 3

Which regulatory registries list Golden Stapler Surgical Co., Ltd’s devices, and why are these important?

Accepted Answer

Golden Stapler Surgical Co., Ltd’s devices are listed in EUDAMED (the EU’s medical device registry), FDA’s 510(k) premarket notification system, and FDA’s Unique Device Identifier (UDI) registry. These registries confirm the devices have undergone necessary evaluations for market authorization in the EU and the US, ensuring transparency, traceability, and compliance with global medical device regulations.

Question 4

How are Golden Stapler Surgical Co., Ltd’s devices classified under regulatory frameworks?

Accepted Answer

Golden Stapler Surgical Co., Ltd’s devices are classified as Class II and Class IIa medical devices. This classification—determined by risk level—requires stricter regulatory oversight compared to lower-risk devices. Class II devices often need performance evaluations, clinical data, or special controls to demonstrate safety and effectiveness before authorization, ensuring higher patient safety standards.

Device	Model / Reference	Registries	Class	Status
Single Use Circular Stapler	CSC32	FDA UDI	Class II	Active
Single Use Circular Stapler	CSC34	FDA UDI	Class II	Active
Single Use Circular Stapler	CSC21	FDA UDI	Class II	Active
Single Use Circular Stapler	CSA34	FDA UDI	Class II	Active
Single Use Circular Stapler	CSB34	FDA UDI	Class II	Active
Single Use Circular Stapler	CSC23	FDA UDI	Class II	Active
Single Use Circular Stapler	CSC26	FDA UDI	Class II	Active
Single Use Circular Stapler	CSC29	FDA UDI	Class II	Active
Single Use Circular Stapler	CSB26	FDA UDI	Class II	Active
Single Patient Use Powered Endo Cutter	Certificate No. G15 004954 0006 Rev. 00	EUDAMED	Class IIa	Active
Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload	K162707	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Single Patient Use Powered Endo Cutter	Certificate No. G15 004954 0006 Rev. 00	EUDAMED	Class IIa	Active

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