Cleared Traditional

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

K250950 · Okapi Medical, LLC Dba Resivant Medical · General & Plastic Surgery

Aug 2025

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K250950 is an FDA 510(k) clearance for the CUTIVA? Topical Skin Adhesive (RM1700); CUTIVA? PLUS Skin Closure System (RM1739), a Tissue Adhesive For The Topical Approximation Of Skin (Class II — Special Controls, product code MPN), submitted by Okapi Medical, LLC Dba Resivant Medical (Akron, US). The FDA issued a Cleared decision on August 4, 2025, 129 days after receiving the submission on March 28, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4010.

Submission Details

510(k) Number	K250950 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2025
Decision Date	August 04, 2025
Days to Decision	129 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	MPN — Tissue Adhesive For The Topical Approximation Of Skin
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4010
Definition	Docket Number: 2006p-0071 - May 5, 2008 - Reclassified From Class 3 Pma To Class 2 510(k).