Cleared Traditional

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)

K234114 · Okapi Medical, LLC Dba Resivant Medical · General & Plastic Surgery

Aug 2024

Decision

237d

Days

Class 2

Risk

About This 510(k) Submission

K234114 is an FDA 510(k) clearance for the CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739), 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 20, 2024, 237 days after receiving the submission on December 27, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4010.

Submission Details

510(k) Number	K234114 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2023
Decision Date	August 20, 2024
Days to Decision	237 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).