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FDA 510(k)

MINT 产品系列（包括 MINT、MINT Lift 和 MINT-I 缝线），MINT Lift ML 1043，MINT Lift ML 1013，MINT Lift 1019，MINT Lift Mini 1014

K号: K220549 · 2023-03-07

申请人Hans Biomed Corporation
决定日期2023-03-07
产品代码NEW
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决定实质等同

器械摘要

MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 is the device name listed in this FDA 510(k) record. The listed applicant is Hans Biomed Corporation. It received FDA 510(k) clearance on 2023-03-07 under 510(k) number K220549. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014?

MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 is a medical device that received FDA 510(k) clearance on 2023-03-07. The listed applicant is Hans Biomed Corporation. The 510(k) number is K220549.

When did MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 receive FDA 510(k) clearance?

MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 received FDA 510(k) clearance on 2023-03-07, under 510(k) number K220549.

Who is the listed applicant for MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014?

FDA 510(k)记录显示汉斯生物医药有限公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014?

The FDA product code for MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 is NEW.

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Hans Biomed Corporation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。

K254238MINT MONO 缝线K192423MINT 产品系列K171568SurFuse凝胶，SurFuse糊状物，ExFuse凝胶，ExFuse糊状物

相关器械（代码：NEW）

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。

K254238MINT MONO 缝线Hans Biomed CorporationK253879单固定PDOSamyang Holdings CorporationK261988Monodek® (POLYDIOXANONE) 染成紫罗兰色的单丝合成可吸收外科缝合线Teleflex Medical, LLCK252171倒刺 PDO 缝线Sutura Medical Technology, Inc.K252047STRATAFIX® 对称 PDS® Plus 无结组织控制装置ETHICON, Inc.K243897PDS™ Plus 抗菌 (聚二氧杂环己酮) 灭菌合成可吸收外科缝合线ETHICON, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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