Chinese manufacturers registered for this device type are concentrated in Anhui, Jiangsu and Shandong, and 1 other province: 4 hold an FDA registration. 1 is a contract manufacturer.
Hook, Gastro-Urology is FDA product code FHB, Class 1, 21 CFR 876.4730.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.