DemeDIOX Barbed Absorbable Surgical Suture
K号: K191361 · 2019-11-07
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决定日期2019-11-07
产品代码NEW
咨询委员会SU
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器械摘要
DemeDIOX Barbed Absorbable Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Demetech Corporation. It received FDA 510(k) clearance on 2019-11-07 under 510(k) number K191361. 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 DemeDIOX Barbed Absorbable Surgical Suture?
DemeDIOX Barbed Absorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2019-11-07. The listed applicant is Demetech Corporation. The 510(k) number is K191361.
When did DemeDIOX Barbed Absorbable Surgical Suture receive FDA 510(k) clearance?
DemeDIOX Barbed Absorbable Surgical Suture received FDA 510(k) clearance on 2019-11-07, under 510(k) number K191361.
Who is the listed applicant for DemeDIOX Barbed Absorbable Surgical Suture?
The FDA 510(k) record lists Demetech Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DemeDIOX Barbed Absorbable Surgical Suture?
The FDA product code for DemeDIOX Barbed Absorbable Surgical Suture 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。
列明Demetech 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。
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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