Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips

The Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are single-use, sterile implantable devices made from non-absorbable acetal polymer for ligating blood vessels and tissue structures during surgical procedures. They are provided in color-coded cartridges and are designed to completely encompass the vessel or tissue being ligated.

The device features a hinged, bow-shaped clip design with bosses for retention within appliers and a locking mechanism. It is offered in Large size only (compared to the predicate's Medium, Medium-Large, Large, and Extra-Large sizes). The clip material, cartridge design (color-coded Easy Load with lateral springs), sterilization method (ethylene oxide at SAL 10⁻⁶), and biocompatibility approach (ISO 10993-1) are identical or equivalent to the predicate.

ISO 10993-1 (biocompatibility framework), ISO 10993-3 (genotoxicity and carcinogenicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization and intracutaneous reactivity), ISO 10993-11 (systemic toxicity, pyrogenicity, and chronic toxicity), and ISO 10993-18 (chemical characterization).

The device is substantially equivalent because it uses identical materials (acetal polymer), identical product code (FZP) and regulation (21 CFR 878.4300), identical intended use and indications for vessel/tissue ligation, and equivalent clip design, cartridge configuration, sterilization, and biocompatibility profile to the predicate K232970. Benchtop performance testing for clip latching, leakage resistance, and removal demonstrated equivalent performance after sterilization and aging.