GEM ZIPCLIP

The GEM ZIPCLIP is a sterile, single-use automatic microclip applier containing 15 preloaded titanium microclips. It is used in surgical procedures to occlude (close off) blood vessels. The device has scissor-like handles that, when squeezed, close the jaws to deploy a titanium clip around a vessel; the clip remains permanently implanted in the patient.

The primary technological difference is that ZIPCLIP integrates the microclip and applier into one preloaded disposable device, whereas the predicate Vitalitec Titanium Hemostatic Clip requires a separate clip applier. Both use identical Grade 1 titanium microclips and operate via the same closure principle—squeezing handles to close jaws around a vessel. ZIPCLIP includes an automatic loading mechanism that deploys a new clip after each firing and a lockout clip (anodized gold) when empty.

Not stated in this summary.

Although ZIPCLIP integrates the clip and applier into a single device while the predicate requires separate components, the final result is identical: a titanium microclip closed around a vessel. Bench testing confirmed ZIPCLIP reliably deploys clips and ligates vessels with no new safety or effectiveness concerns. The predicate and subject device share the same titanium material, basic clip design, and closure principle. Similar integrated clip-applier devices already exist on the market (e.g., Covidien Premium SurgiClip III), demonstrating that this design integration does not raise new questions of safety or efficacy.