Cleared Traditional

K234114 - CUTIVA(TM) Topical Skin Adhesive (RM-1700) (FDA 510(k) Clearance)

Also includes:
CUTIVA(TM) PLUS Skin Closure System (RM-1739)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K234114 · Okapi Medical, LLC Dba Resivant Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
237d
Days
Class 2
Risk

K234114 is an FDA 510(k) clearance for the CUTIVA(TM) Topical Skin Adhesive (RM-1700). Classified as Tissue Adhesive For The Topical Approximation Of Skin (product code MPN), Class II - Special Controls.

Submitted by Okapi Medical, LLC Dba Resivant Medical (Akron, US). The FDA issued a Cleared decision on August 20, 2024 after a review of 237 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4010 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Okapi Medical, LLC Dba Resivant Medical devices

Submission Details

510(k) Number K234114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 114d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MPN Tissue Adhesive For The Topical Approximation Of Skin
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - MPN Tissue Adhesive For The Topical Approximation Of Skin

All 35
Devices cleared under the same product code (MPN) and FDA review panel - the closest regulatory comparables to K234114.
BondEase 2 Topical Skin Adhesive
K243990 · Optmed, Inc. · Sep 2025
CUTIVA™ Topical Skin Adhesive (RM1700)
K250950 · Okapi Medical, LLC Dba Resivant Medical · Aug 2025
CM005 Standard (CM005)
K233458 · Connexicon Medical , Ltd. · Jul 2024
Meriglu Topical Skin Adhesive
K230981 · M/s. Meril Endo Surgery Private Limited. · Mar 2024
Exofin Precision Pen
K212246 · Chemence Medical, Inc. · Sep 2021