Basin for Endoscope Reprocessing

What Is It?

To allow endoscopes to soak in reprocessing solutions.

What Is FDA Product Code PHT?

Basin For Endoscope Reprocessing is FDA product code PHT, Class 1, 21 CFR 876.1500.

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.