Hemostatic Metal Clip for the Gi Tract

What Is This Device?

Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.

What Is FDA Product Code PKL?

Hemostatic Metal Clip For The Gi Tract is FDA product code PKL, Class 2, 21 CFR 876.4400.

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 26 clearances under this code; the FDA took a median of 213 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 6 recalls under this product code since 2019. None was by a company in China. The root causes the FDA records most often are Device Design (1) and Process control (1).

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