Hemoclip

The Hemoclip is an endoscopic metal clip delivery system for use in the digestive tract of adult patients via flexible endoscopy. It is indicated for endoscopic marking, hemostasis of mucosal defects and bleeding vessels, anchoring jejunal feeding tubes, and supplementary closure of small GI perforations. The clip remains in place for 1-2 weeks before naturally falling off and being discharged.

The proposed device features a sliding handle mechanism for clip deployment (versus a simple handle on the predicate), claw angles of 90° and 135°, rotation and removability performance, MR Unsafe designation (predicate is MR Conditional), a three-year shelf life (versus two years), and the ability to be removed intraoperatively using a polypectomy snare. Materials are stainless steel and polymer for both devices.

ISO 10993 (biocompatibility) and ISO 11135 (sterility) are cited as design specifications and medical device standards met by the Hemoclip. Non-clinical performance testing including bench tests for claw angle, rotation performance, and removability were conducted.

The Hemoclip is substantially equivalent to the Lockado Repositionable Hemostasis Clip predicate because both are metal clips for hemostasis and marking in the GI tract with the same intended use, same product code (PKL), same regulatory classification (Class II, 21 CFR 876.4400), and similar materials and function. Differences in handle design, removability features, and shelf life do not raise safety or effectiveness concerns and are supported by bench testing.