Staple Removal Kit
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Jiangsu Classic NEW-Type Medical Products Co., Ltd. Jiangsu, contract manufacturer
What Is This Device?
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
What Is FDA Product Code PYE?
Staple Removal Kit is FDA product code PYE, Class 1, 21 CFR 878.4760.
How Does It Reach the US Market?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.