TroClose 1200

The TroClose1200™ is a trocar system used in gynecologic, general, and urologic laparoscopic surgery to create and maintain an access port for surgical instruments. It consists of a bladeless obturator for insertion and a cannula pre-loaded with two absorbable sutures and anchors that deploy to close the surgical access site.

The device has identical intended use and technological characteristics to its predicates. Minor component material changes include the reducer (polyisoprene instead of perylene-coated silicon), deployment handle (polycarbonate instead of IXCF®), pushers (300 series stainless steel instead of 17-4pH alloy), and obturator housing (Grivory instead of IXCF®). The closure device anchors and sutures remain identical to the predicate.

Testing per USP monographs for absorbable sutures (knot pull tensile strength, needle attachment tensile strength, diameter, length), ISO 10993-1 for biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity, pyrogenicity), ISO 11135 for sterilization validation, and ISO 11607 for packaging validation.

The TroClose1200™ is substantially equivalent to its predicates (K171494, K160564) because it maintains identical intended use, identical technological principles of operation, identical closure device anchors and sutures, and biocompatible materials. Performance testing confirmed that minor design and material modifications do not impact functionality or present new safety or effectiveness concerns.