Suture, Surgical, Absorbable, Polydioxanone

What Is FDA Product Code NEW?

Suture, Surgical, Absorbable, Polydioxanone is FDA product code NEW, Class 2, 21 CFR 878.4840.

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. Chinese applicants hold 2 clearances under this code; the FDA took a median of 150 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 40 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Process control (11), Labeling Change Control (5) and Employee error (2).

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