OverStitch 2-0 聚丙烯缝合线
K号: K191439 · 2019-08-29
广告
决定日期2019-08-29
产品代码OCW
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
OverStitch 2-0 Polypropylene Suture is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Endosurgery. It received FDA 510(k) clearance on 2019-08-29 under 510(k) number K191439. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OverStitch 2-0 Polypropylene Suture?
OverStitch 2-0 Polypropylene Suture is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Apollo Endosurgery. The 510(k) number is K191439.
When did OverStitch 2-0 Polypropylene Suture receive FDA 510(k) clearance?
OverStitch 2-0 Polypropylene Suture received FDA 510(k) clearance on 2019-08-29, under 510(k) number K191439.
Who is the listed applicant for OverStitch 2-0 Polypropylene Suture?
The FDA 510(k) record lists Apollo Endosurgery as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OverStitch 2-0 Polypropylene Suture?
The FDA product code for OverStitch 2-0 Polypropylene Suture is OCW.
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Apollo Endosurgery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：OCW）
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。
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