What Is This Device?
Acts as a barrier to the passage of fecal matter through the rectum.
How Is PBP Classified?
Rectal Insert is FDA product code PBP, Class 2, 21 CFR 876.5980.
What Does It Take to Sell It in the United States?
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. The review can be done by an FDA-accredited third party, which is usually faster. 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.