CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)

CUTIVA™ Topical Skin Adhesive (RM1700) and CUTIVA™ PLUS Skin Closure System (RM1739) are topical skin closure devices containing 2-octyl cyanoacrylate liquid adhesive supplied in single-use applicators. The PLUS variant includes a self-adhering mesh component that aligns skin edges before adhesive application. Both are intended for topical closure of easily approximated surgical incisions and simple lacerations, used alongside but not replacing deep dermal stitches.

The technological characteristics are identical to the predicate devices (K234114). No changes were introduced to device design, packaging, manufacturing processes, or sterilization processes. The only modifications in this submission are labeling changes: removal of a maximum-use-per-patient limitation for both devices and addition of exudate management instructions for the PLUS variant.

ISO 10993-11:2017 (Subacute Systemic Toxicity, Implant Method in Rats) was performed to evaluate biocompatibility and support the labeling changes. In vitro microbial barrier studies were conducted for 72 hours post-application, though no clinical studies were performed.

Substantial equivalence is established because the CUTIVA devices are physically and functionally identical to their predicates—each device references itself as predicate since both were originally cleared under K234114. Only labeling modifications were made: removing dosing restrictions supported by biocompatibility data showing no systemic toxicity, and adding practical use instructions. Since the devices unchanged in design and manufacturing remain substantively equivalent to themselves, the labeling updates do not affect substantial equivalence.