ArcTO 经闭式吊带系统
K号: K222468 · 2022-09-15
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器械摘要
ArcTO Transobturator Sling System is the device name listed in this FDA 510(k) record. The listed applicant is Urocure, LLC. It received FDA 510(k) clearance on 2022-09-15 under 510(k) number K222468. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ArcTO Transobturator Sling System?
ArcTO Transobturator Sling System is a medical device that received FDA 510(k) clearance on 2022-09-15. The listed applicant is Urocure, LLC. The 510(k) number is K222468.
When did ArcTO Transobturator Sling System receive FDA 510(k) clearance?
ArcTO Transobturator Sling System received FDA 510(k) clearance on 2022-09-15, under 510(k) number K222468.
Who is the listed applicant for ArcTO Transobturator Sling System?
The FDA 510(k) record lists Urocure, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ArcTO Transobturator Sling System?
The FDA product code for ArcTO Transobturator Sling System is OTN.
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Urocure, LLC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：OTN）
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。
K231549Advantage Ultra System，Advantage Fit Ultra System，Lynx Ultra SystemBoston Scientific CorporationK222293ArcSP Suprapubic Sling SystemUrocure, LLCK211975Desara TV EZ 3.0 系统，Desara Blue TV EZ 3.0 系统，Desara TV EZ 2.7 系统，Desara Blue TV EZ 2.7 系统Caldera Medical, Inc.K211223Advantage Ultra System，Advantage Fit Ultra System，Lynx Ultra SystemBoston Scientific CorporationK210087Athena 手术 RMUS 系统Athena Surgical, LLCK201686GYNECARE TVT™系统，GYNECARE TVT™腹部导引器系统，GYNECARE TVT™导引器和导管导引器，GYNECARE TVT EXACT™排尿系统和套管，GYNECARE TVT™闭孔系统、传递器和翼形导引器，GYNECARE TVT ABBREVO™排尿系统和传递器、翼形导引器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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