SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)

The SimpleSnip Endoscopic Suture Cutter is a sterile, single-use device designed to cut sutures during flexible endoscopic procedures. It passes through the working channel of endoscopes with a minimum 2.8mm diameter and is available in two working lengths: 160cm for gastroscopes and 230cm for colonoscopes. The device uses a proximal handle to advance and retract a rotatable J-hook-shaped cutting blade to capture and sever sutures.

The SimpleSnip has a single cutting blade versus the predicate's double-blade scissor configuration. Its working lengths are 5cm shorter than the predicate Ensizor device. Both are non-powered, disposable, single-use instruments sterilized via ethylene oxide to SAL 10⁻⁶, compatible with flexible endoscopes, and use proximal sliding handle actuation. The SimpleSnip's shaft diameter is 2.5mm compared to the predicate's 2.6mm; the SimpleSnip blade is 5.0mm versus the predicate's 10mm.

ISO 10993-1 (biocompatibility evaluation), ISO 11135 (ethylene oxide sterilization validation). Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity. Performance testing included dimensional verification, functionality testing (suture cutting at least 20 times), destructive testing (tensile strength), packaging verification, and shelf-life studies.

The SimpleSnip is substantially equivalent because it shares the same intended use (suture cutting in flexible endoscopy), fundamental operating principle (proximal handle actuation to advance/retract a blade to cut sutures), and regulatory classification (Class II, 21 CFR 876.1500, product code OCZ) as the predicate Ensizor scissors. Although the SimpleSnip has a single blade versus scissors configuration and 5cm shorter working length, comparative testing demonstrated it performs as well or better than the predicate in rotating blades through tortuous paths, cutting various suture types/sizes, and bending stiffness. Both serve the same patient population and neither has electrocautery. The narrower indications for use (suture cutting only versus tissue dissection and cutting) represent a subset that does not negatively impact substantial equivalence.