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 STERIS Corporation.
FDA 510(k) Cleared Hemostatic Metal Clip For The Gi Tract Devices (Product Code PKL)
About Product Code PKL - Regulatory Context
510(k) Submission Activity
62 total 510(k) submissions under product code PKL since 1997, with 62 receiving FDA clearance (average review time: 163 days).
Submission volume has remained relatively stable over the observed period, with 13 submissions in the last 24 months.
FDA Review Time
FDA review times for PKL submissions have been consistent, averaging 160 days recently vs 164 days historically.
PKL devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →