Cannula, Injector, Uterine, Endometrial Biopsy
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Jiangsu and Zhejiang: 2 hold an FDA registration.
- Goals Sterilization Co., Ltd. Zhejiang, contract manufacturer
- Wuxi Goals Medical Technology Co., Ltd. Jiangsu, contract manufacturer
What Is This Device?
to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy
What Is FDA Product Code PGK?
Cannula, Injector, Uterine, Endometrial Biopsy is FDA product code PGK, Class 2, 21 CFR 884.4530.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.