Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)

The Single Use Electrosurgical Knife (KD-612, KD-620UR, KD-650 series) is a sterile, single-use device designed to cut tissue using high-frequency electrical current within the digestive tract. It is used in combination with an endoscope and electrosurgical units and consists of a handle with a slider mechanism that extends and retracts a stainless-steel cutting knife from a sheath.

The device uses high-frequency current to cut tissue and is provided sterile via ethylene oxide sterilization. The primary technological difference is minor dimensional variations between models, but all share the same basic operating principles. The device is comprised of a handle, slider mechanism, and insertion portion with a distal cutting knife and sheath.

Not stated in this summary.

The subject devices are substantially equivalent to their respective predicates (KD-611L, KD-625UR, KD-655L/U) because they have identical or nearly identical intended uses for cutting tissue in the digestive tract, employ the same high-frequency current operating principle, and all performance bench tests (insertion, slider operation, cutting ability, connection strength, thermal evaluation, and human factors) demonstrated equivalent safety and effectiveness with no new safety issues identified.