Dual Action Tissue Closure Device

The Dual Action Tissue Closure Device is a sterile, single-use endoscopic clipping instrument designed for flexible endoscopy procedures in the gastrointestinal tract. It compresses and clips tissue for endoscopic marking, hemostasis of bleeding sources (ulcers, polyps, mucosal defects, arteries), and as supplementary closure of GI perforations up to 20 mm that can be managed conservatively.

The device features two handles controlling two independent clips with a metallic clasping mechanism operated by steel wire pulleys. Key differences from the predicate include: smaller minimal working channel (2.8 mm vs. 3.2 mm), multiple open-width options (9–18 mm vs. fixed 15±3 mm), optional lateral teeth, and improved rotation performance and torque specifications aligned with a reference device (K202333).

ISO 11135:2014 (ethylene oxide sterilization validation), ISO 10993-1 (biocompatibility), ASTM F 2503/F 2052/F 2119/F 2182/F 2213 (MRI safety), ASTM F 1980-21 (accelerated shelf-life aging). Device dimensions, clip mechanics, scope compatibility, force measurements, tensile strength, clamping strength, and MRI safety were evaluated per these standards.

The device incorporates the same fundamental design, configuration, principles of operation, control mechanism, working lengths, sterilization process, and packaging as the predicate device K233772. Although the proposed device has minor dimensional and operational enhancements (smaller working channel, variable clip widths, lateral teeth options, improved torque), these represent refinements to a substantially equivalent platform. Performance testing confirms equivalence to the predicate for all core functions, with rotation/torque specifications borrowed from an approved reference device. No new safety risks or mechanisms of action are introduced.