CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739)— 510(k) K250950

Name: FDA 510(k) clearance K250950
Creator: U.S. Food and Drug Administration
Published: 2025-08-04

Substantially Equivalent

Okapi Medical, LLC Dba Resivant Medical

FDA 510(k) clearance K250950 for CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739), Substantially Equivalent on 2025-08-04. Applicant: Okapi Medical, LLC Dba Resivant Medical. Device class: 2.

Clearance details

Applicant: Okapi Medical, LLC Dba Resivant Medical
Product code: Code MPN
Device class: Class 2
Regulation: 21 CFR 878.4010
Advisory panel: General, Plastic Surgery
Date received: 2025-03-28
Decision date: 2025-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MPN

view all

K243990 — BondEase 2 Topical Skin Adhesive2025-09-19
K234114 — CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)2024-08-20
K233458 — CM005 Standard (CM005); CM004 Mini (CM004)2024-07-15
K230981 — Meriglu Topical Skin Adhesive2024-03-16
K212246 — Exofin Precision Pen2021-09-09

Adverse events under product code MPN

product code MPN

Injury: 856
Other: 1
Total: 857

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.