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FDA 510(k)

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

K-Number: K234114 · 2024-08-20

ApplicantOkapi Medical, LLC Dba Resivant Medical
Decision Date2024-08-20
Product CodeMPN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) is a medical device manufactured by Okapi Medical, LLC Dba Resivant Medical. It received FDA 510(k) clearance on 2024-08-20 under approval number K234114. The device is classified under product code MPN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)?

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) is a medical device that received FDA 510(k) clearance on 2024-08-20. It is manufactured by Okapi Medical, LLC Dba Resivant Medical. The 510(k) number is K234114.

When was CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) approved by the FDA?

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) received FDA 510(k) clearance on 2024-08-20, under approval number K234114.

What company makes CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)?

CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) is manufactured by Okapi Medical, LLC Dba Resivant Medical.

What is the FDA product code for CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)?

The FDA product code for CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) is MPN.

Related Clinical Trials

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Other Devices by Okapi Medical, LLC Dba Resivant Medical

K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)

Related Devices (Code: MPN)

K162352derma+flex QS High Viscosity Tissue AdhesiveChemence Medical, Inc. K161011SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin AdhesiveAdhezion Biomedical, LLC K161050ACTABOND Topical Skin AdhesiveBergen Medical Products, Inc. K152476Exofin High Viscosity Tissue AdhesiveChemence Medical Products, Inc. K150032GluStitch Twist Tissue AdhesiveGlustitch, Inc. K200264Exofin High Viscosity Topical Skin AdhesiveChemence Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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