FDA 510(k)

Sutil Pure个人润滑剂（型号1148，1145，1146，1147）

K号: K252914 · 2026-06-09

决定日期2026-06-09

产品代码NUC

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决定实质等同

器械摘要

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) is the device name listed in this FDA 510(k) record. The listed applicant is Hathor Professional Skincare , Ltd.. It received FDA 510(k) clearance on 2026-06-09 under 510(k) number K252914. 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 Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)?

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) is a medical device that received FDA 510(k) clearance on 2026-06-09. The listed applicant is Hathor Professional Skincare , Ltd.. The 510(k) number is K252914.

When did Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) receive FDA 510(k) clearance?

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) received FDA 510(k) clearance on 2026-06-09, under 510(k) number K252914.

Who is the listed applicant for Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)?

The FDA 510(k) record lists Hathor Professional Skincare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)?

The FDA product code for Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) is NUC.

列明Hathor Professional Skincare , 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。

K250629Sutil Rich个人润滑剂 K241443Sutil Luxe个人润滑剂（型号1126，0009，0010，0011）；Sutil Luxe香草个人润滑剂（型号1119，1120）；Sutil Luxe椰子个人润滑剂（型号1121，1122）；Sutil Luxe薄荷个人润滑剂（型号1117，1118）

官方来源

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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。