CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)— 510(k) K234114

Substantially Equivalent

Okapi Medical, LLC Dba Resivant Medical

FDA 510(k) clearance K234114 for CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739), Substantially Equivalent on 2024-08-20. Applicant: Okapi Medical, LLC Dba Resivant Medical.

Clearance details

Applicant: Okapi Medical, LLC Dba Resivant Medical
Product code: Code MPN
Advisory panel: General, Plastic Surgery
Date received: 2023-12-27
Decision date: 2024-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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.