FDA 510(k)

OverStitch 内窥镜缝合系统及附件

K号: K181141 · 2018-06-27

决定日期2018-06-27

产品代码OCW

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决定实质等同

器械摘要

OverStitch Endoscopic Suturing System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Endosurgery. It received FDA 510(k) clearance on 2018-06-27 under 510(k) number K181141. 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 Endoscopic Suturing System and Accessories?

OverStitch Endoscopic Suturing System and Accessories is a medical device that received FDA 510(k) clearance on 2018-06-27. The listed applicant is Apollo Endosurgery. The 510(k) number is K181141.

When did OverStitch Endoscopic Suturing System and Accessories receive FDA 510(k) clearance?

OverStitch Endoscopic Suturing System and Accessories received FDA 510(k) clearance on 2018-06-27, under 510(k) number K181141.

Who is the listed applicant for OverStitch Endoscopic Suturing System and Accessories?

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 Endoscopic Suturing System and Accessories?

The FDA product code for OverStitch Endoscopic Suturing System and Accessories is OCW.

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。

K191439OverStitch 2-0 聚丙烯缝合线

官方来源

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