FDA 510(k)

U by Kotex 点击无香卫生巾

K号: K172118 · 2017-10-11

决定日期2017-10-11

产品代码HEB

咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

U by Kotex Click Unscented Menstrual Tampons is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corporation. It received FDA 510(k) clearance on 2017-10-11 under 510(k) number K172118. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the U by Kotex Click Unscented Menstrual Tampons?

U by Kotex Click Unscented Menstrual Tampons is a medical device that received FDA 510(k) clearance on 2017-10-11. The listed applicant is Kimberly-Clark Corporation. The 510(k) number is K172118.

When did U by Kotex Click Unscented Menstrual Tampons receive FDA 510(k) clearance?

U by Kotex Click Unscented Menstrual Tampons received FDA 510(k) clearance on 2017-10-11, under 510(k) number K172118.

Who is the listed applicant for U by Kotex Click Unscented Menstrual Tampons?

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

What is the FDA product code for U by Kotex Click Unscented Menstrual Tampons?

The FDA product code for U by Kotex Click Unscented Menstrual Tampons is HEB.

列明Kimberly-Clark Corporation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。

K231435KIMTECH™ Polaris™ Xtra 乳胶粉未检查手套，用于化疗药物，阿片类芬太尼柠檬酸盐，模拟胃酸和模拟胃酸中的芬太尼 K231021KIMTECH™ Polaris™ 乳胶粉未检查手套，用于化疗药物，阿片类芬太尼柠檬酸盐，模拟胃酸和模拟胃酸中的芬太尼 K223749U by Kotex® Click® 无香卫生巾 K202416Kimtech Prizm多层检查手套，用于化疗药物，阿片类药物芬太尼盐酸盐，模拟胃酸和胃酸中的芬太尼，Kimtech Prizm Xtra多层检查手套，用于化疗药物，阿片类药物芬太尼盐酸盐，模拟胃酸和胃酸中的芬太尼 K200072KIMTECH紫色乳胶粉未检查手套，用于化疗药物，阿片类芬太尼，胃酸和胃酸中的芬太尼

相关器械（代码：HEB）

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。

K252005Livi 设备Liviwell, Inc.K253719无香月经长型推杆卫生巾；无香月经纸盒推杆卫生巾；无香月经数字卫生巾Unibeauty (Hubei) Technology Co., Ltd.K252939COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONSCotton High Tech S.L.K252613无香型三件套月经棒Unibeauty (Hubei) Technology Co., Ltd.K251033无香型月经长型棒状卫生棉条；无香型月经紧凑型棒状卫生棉条；无香型月经纸盒型棒状卫生棉条；无香型月经数字型卫生棉条Unibeauty (Hubei) Technology Co., Ltd.K242105SABA 棉签Essity Higiene Y Salud Mexico. S.A. DE C.V.

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。