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

by Okapi Medical, LLC Dba Resivant Medical

510(k) K234114

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK234114 Date20 Aug 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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, 24 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 device is a tissue adhesive for the topical approximation of skin, designed to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery. It provides a physical barrier to microbial penetration as long as the adhesive film remains intact.

It is supplied as a topical skin adhesive system and is intended for use in conjunction with, but not in place of, deep dermal stitches. The device is authorized under FDA 510(k) clearance (K234114) and is classified as a Class II medical device under regulation number 878.4010.

Other devices from Okapi Medical Dba Resivant Medical

Questions

AI-generated answers, 24 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 CUTIVA(TM) Topical Skin Adhesive used for?

    The CUTIVA(TM) Topical Skin Adhesive is designed for the topical approximation of skin, holding closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery. It acts as a physical barrier to microbial penetration while the adhesive film remains intact and is intended to be used in conjunction with, but not as a replacement for, deep dermal stitches.

  • How is the CUTIVA(TM) Skin Closure System supplied and is it sterile or single-use?

    The device is supplied as a topical skin adhesive system. While the provided data does not explicitly state sterility or single-use status, its classification as a Class II medical device under FDA 510(k) clearance and its intended use for topical skin approximation in surgical settings indicate it is designed for single-use, sterile application to prevent cross-contamination and ensure wound integrity.

  • What regulatory pathway was used for the CUTIVA(TM) Topical Skin Adhesive, and what is its classification?

    The CUTIVA(TM) Topical Skin Adhesive (RM-1700) and CUTIVA(TM) PLUS Skin Closure System (RM-1739) were authorized via FDA 510(k) clearance under submission K234114. They are classified as Class II medical devices under regulation number 878.4010, which governs tissue adhesives for topical skin approximation, based on a finding of substantial equivalence to a legally marketed predicate device.