Acanthus
Acanthus Condom Catheter Medium-Large with 3ml Skin Adhesive
Sheath, Corrugated Rubber, for Non-Indwelling Catheter, Non-Sterile
Which Manufacturers in China Make This?
4 manufacturers in China hold an FDA registration for this device type, concentrated in Hubei, Jiangsu and Shandong, and 1 other province.
- Fesun Shanghai Co., Ltd. Shanghai, contract manufacturer
- JM Medical Co., Ltd. Shandong, contract manufacturer
- Suzhou Texnet Jiangsu, contract manufacturer
- Wuhan Sitaili Medical Apparatus Development Co., Ltd. Hubei
What Is It?
Urine collector and accessories; see product code EYT.
How Is NNY Classified?
Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile is FDA product code NNY, Class 1, 21 CFR 876.5250.
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. It is also exempt from most of the quality system regulation.
What Has Gone Wrong With It?
The FDA has recorded 3 recalls under this product code since 2011. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.