Agent, Absorbable Hemostatic, Non-Collagen Based

How Is LMG Classified?

Agent, Absorbable Hemostatic, Non-Collagen Based is FDA product code LMG, Class 3, 21 CFR 878.4490.

What Does It Take to Sell It in the United States?

A premarket approval is required: the Class 3 route, granted on clinical evidence rather than on equivalence to an existing device. No approval under this code names a Chinese applicant.

What Do the Recalls Say?

The FDA has recorded 4 recalls under this product code since 2024. None was by a company in China. The root causes the FDA records most often are No Marketing Application (2) and Process control (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.