FDA 510(k)

Astroglide Ultra 温和凝胶

K号: K220355 · 2022-05-26

决定日期2022-05-26

产品代码NUC

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决定实质等同

器械摘要

Astroglide Ultra Gentle Gel is the device name listed in this FDA 510(k) record. The listed applicant is Biofilm, Inc.. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K220355. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Astroglide Ultra Gentle Gel?

Astroglide Ultra Gentle Gel is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is Biofilm, Inc.. The 510(k) number is K220355.

When did Astroglide Ultra Gentle Gel receive FDA 510(k) clearance?

Astroglide Ultra Gentle Gel received FDA 510(k) clearance on 2022-05-26, under 510(k) number K220355.

Who is the listed applicant for Astroglide Ultra Gentle Gel?

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

What is the FDA product code for Astroglide Ultra Gentle Gel?

The FDA product code for Astroglide Ultra Gentle Gel is NUC.

列明Biofilm, Inc.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。

K221036Astroglide 加热 K220653Astroglide 羟基与对羟基苯甲酸酯免费 K213671Astroglide Sensual 草莓个人润滑剂 K210242Astroglide X 硅胶个人润滑剂 K200239Astroglide Organix 凝胶 K200114Astroglide Organix 液体

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