FDA 510(k)

水溶性个人润滑剂

K号: K212104 · 2021-11-18

申请人Foshan Pingchuang Medical Technology Co., Ltd.

决定日期2021-11-18

产品代码NUC

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

Water-soluble Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Pingchuang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K212104. 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 Water-soluble Personal Lubricant?

Water-soluble Personal Lubricant is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Foshan Pingchuang Medical Technology Co., Ltd.. The 510(k) number is K212104.

When did Water-soluble Personal Lubricant receive FDA 510(k) clearance?

Water-soluble Personal Lubricant received FDA 510(k) clearance on 2021-11-18, under 510(k) number K212104.

Who is the listed applicant for Water-soluble Personal Lubricant?

The FDA 510(k) record lists Foshan Pingchuang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Water-soluble Personal Lubricant?

The FDA product code for Water-soluble Personal Lubricant is NUC.

列明Foshan Pingchuang Medical Technology Co., Ltd.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。

K253255非灭菌超声凝胶无菌超声凝胶 K252935Hybrid 个人润滑剂（水&硅）（5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml）

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。