Pneumoperitoneum Needle

What Is It?

For establishment of a pneumoperitoneum in abdomen.

What Is FDA Product Code FHO?

Pneumoperitoneum Needle is FDA product code FHO, Class 2, 21 CFR 876.1500.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 1 clearance under this code; the FDA took 63 days from receipt to decision.