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

by Okapi Medical, LLC Dba Resivant Medical

510(k) K250950

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250950 Date4 Aug 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MPN
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4010
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cutiva Topical Skin Adhesive and Cutiva Plus Skin Closure System are tissue adhesives used for the topical approximation of skin. These devices provide a physical barrier to microbial penetration as long as the adhesive film remains intact.

The Cutiva Plus Skin Closure System is intended for topical application to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. This device has received FDA 510k clearance.

Other devices from Okapi Medical Dba Resivant Medical

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Cutiva Skin Closure System?

    The Cutiva Plus Skin Closure System is intended for the topical application to hold closed easily approximated skin edges. This includes wounds from surgical incisions, such as punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.

  • How does the Cutiva adhesive protect a wound?

    These devices function by providing a physical barrier to microbial penetration. This protective barrier remains effective as long as the adhesive film applied to the skin remains intact.

  • What is the regulatory status of these devices?

    The Cutiva Plus Skin Closure System has received FDA 510k clearance. The device is classified under regulation number 878.4010 for tissue adhesives used for the topical approximation of skin.