Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)

The Resolution Clip is a sterile, single-use endoscopic clipping device for placement within the gastrointestinal tract. It is indicated for endoscopic marking, hemostasis of bleeding ulcers and lesions, anchoring feeding tubes and stents, and supplemental closure of luminal perforations. The device consists of a handle assembly, delivery catheter (155cm or 235cm working length), and a metal clip with stainless-steel arms, cobalt chrome yoke, and styrene tension breaker.

The primary modification from the predicate device (K222503) is removal of the outer sheath component from the Resolution Clip delivery system. The clip design, materials, working lengths, and functional capabilities (including five open-close cycles before deployment) remain unchanged. The device remains compatible with endoscopes having working channels ≥2.8 mm.

Not stated in this summary.

The design modification removes only the outer sheath component while maintaining all functional performance characteristics. Bench simulated-use testing confirmed the device without the outer sheath continues to meet existing performance requirements for device removal from the endoscope, device passability within the endoscope, and absence of endoscope working channel damage. Since the clip mechanism, materials, indications, and clinical performance remain identical to the predicate, the modification does not affect substantial equivalence.