Coagulator, Laparoscopic, Unipolar (And Accessories)

How Is HFG Classified?

Coagulator, Laparoscopic, Unipolar (And Accessories) is FDA product code HFG, Class 2, 21 CFR 884.4160.

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. 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.