D and C Tray
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Zhejiang.
- GRI Medical & Electronic Technology Co., Ltd. Zhejiang, contract manufacturer
What Is It?
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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
How Is PKF Classified?
D And C Tray is FDA product code PKF, not classified.
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.
What Do the Recalls Say?
The FDA has recorded 2 recalls under this product code since 2022. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (1) and Process change control (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.