FDA 510(k)

Signia sterilization tray

K号: K161347 · 2016-09-07

决定日期2016-09-07

产品代码KCT

咨询委员会HO

决定Substantially Equivalent

器械摘要

Signia sterilization tray is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-09-07 under 510(k) number K161347. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Signia sterilization tray?

Signia sterilization tray is a medical device that received FDA 510(k) clearance on 2016-09-07. The listed applicant is Covidien. The 510(k) number is K161347.

When did Signia sterilization tray receive FDA 510(k) clearance?

Signia sterilization tray received FDA 510(k) clearance on 2016-09-07, under 510(k) number K161347.

Who is the listed applicant for Signia sterilization tray?

The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Signia sterilization tray?

The FDA product code for Signia sterilization tray is KCT.

列明Covidien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。

K241486Sofsilk™ Coated Braided Silk Suture K240077Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)K231934GIA™ Stapler with Tri-Staple™ Technology K231240MaxTack™ Motorized Fixation Device K223130Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)K232126EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil

查看所有 61 个设备 →

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。