Biopsy Needle Kit
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Zhejiang.
- GRI Medical & Electronic Technology Co., Ltd. Zhejiang, 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.
How Is POZ Classified?
Biopsy Needle Kit is FDA product code POZ, Class 2, 21 CFR 876.1075.
What Does It Take to Sell It in the United States?
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.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2026. None was by a company in China. 1 is Class I, the most serious grade.
The root cause the FDA records most often is Nonconforming Material/Component (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.