SoftFix球囊穿刺器
K号: K211577 · 2021-11-05
广告
决定日期2021-11-05
产品代码GCJ
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
SoftFix Balloon Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Unimax Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-11-05 under 510(k) number K211577. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SoftFix Balloon Trocar?
SoftFix Balloon Trocar is a medical device that received FDA 510(k) clearance on 2021-11-05. The listed applicant is Unimax Medical Systems, Inc.. The 510(k) number is K211577.
When did SoftFix Balloon Trocar receive FDA 510(k) clearance?
SoftFix Balloon Trocar received FDA 510(k) clearance on 2021-11-05, under 510(k) number K211577.
Who is the listed applicant for SoftFix Balloon Trocar?
The FDA 510(k) record lists Unimax Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SoftFix Balloon Trocar?
The FDA product code for SoftFix Balloon Trocar is GCJ.
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。
相关器械（代码：GCJ）
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。
K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE选择系统Karl Storz SE & CO. KGK260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony CorporationK261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLCK253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical ImpactK261614LED液晶显示器（OEV-271H）Lg Electronics.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。
广告