FDA Product Code PKL: Hemostatic Metal Clip For The Gi Tract

Gastrointestinal bleeding is one of the most common endoscopic emergencies. FDA product code PKL covers hemostatic metal clips for use in the gastrointestinal tract.

These devices are deployed through an endoscope to mechanically compress bleeding vessels or close mucosal defects — including perforations, ulcers, and post-polypectomy sites. They provide immediate mechanical hemostasis without thermal injury to surrounding tissue.

PKL devices are Class II medical devices, regulated under 21 CFR 876.4400 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Micro-Tech (Nanjing) Co., Ltd., Boston Scientific Corporation and Ovesco Endoscopy AG.