FDA 510(k)

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

N.º K: K234114 · 2024-08-20

SolicitanteOkapi Medical, LLC Dba Resivant Medical

Fecha de decisión2024-08-20

Código de productoMPN

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

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. The listed applicant is Okapi Medical, LLC Dba Resivant Medical. The 510(k) number is K234114.

When did CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739) receive FDA 510(k) clearance?

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 510(k) number K234114.

Who is the listed applicant for CUTIVA(TM) Topical Skin Adhesive (RM-1700); CUTIVA(TM) PLUS Skin Closure System (RM-1739)?

The FDA 510(k) record lists Okapi Medical, LLC Dba Resivant Medical as the applicant. This does not by itself establish the device manufacturer.

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Okapi Medical, LLC Dba Resivant Medical como solicitante

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

Dispositivos relacionados (Código: MPN)

K243990BondEase 2 Topical Skin AdhesiveOptmed, Inc.K250950CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)Okapi Medical, LLC Dba Resivant Medical K233458CM005 Standard (CM005); CM004 Mini (CM004)Connexicon Medical , Ltd.K230981Meriglu Topical Skin AdhesiveM/s. Meril Endo Surgery Private Limited.K212246Exofin Precision PenChemence Medical, Inc.K200264Exofin High Viscosity Topical Skin AdhesiveChemence Medical, Inc.

Fuente oficial

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