What Is It?
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
What Is FDA Product Code GAG?
Stapler, Surgical is FDA product code GAG, Class 2, 21 CFR 878.4740.
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. Chinese applicants hold 2 clearances under this code; the FDA took a median of 74 days from receipt to decision on them. One went the Special 510(k) route, the one for a change to the applicant’s own cleared device.
What Has Gone Wrong With It?
The FDA has recorded 10 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Packaging process control (2), Employee error (2) and Nonconforming Material/Component (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.