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FDA 510(k)

CUTIVA™局部皮肤粘合剂（RM-1700）；CUTIVA™ PLUS皮肤闭合系统（RM-1739）

K号: K234114 · 2024-08-20

申请人Okapi Medical, LLC Dba Resivant Medical
决定日期2024-08-20
产品代码MPN
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Okapi Medical, LLC Dba Resivant Medical为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250950CUTIVA™局部皮肤粘合剂（RM1700）；CUTIVA™ PLUS皮肤闭合系统（RM1739）

相关器械（代码：MPN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K243990BondEase 2 表面皮肤粘合剂Optmed, Inc.K250950CUTIVA™局部皮肤粘合剂（RM1700）；CUTIVA™ PLUS皮肤闭合系统（RM1739）Okapi Medical, LLC Dba Resivant MedicalK233458CM005 标准 (CM005)；CM004 迷你 (CM004)Connexicon Medical , Ltd.K230981Meriglu局部皮肤粘合剂M/s. Meril Endo Surgery Private Limited.K212246Exofin 精密笔Chemence Medical, Inc.K200264Exofin 高粘度局部皮肤粘合剂Chemence Medical, Inc.

官方来源

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