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FDA 510(k)

PR 水基润滑剂个人润滑剂（PR 水基润滑剂个人润滑剂）

K号: K261292 · 2026-06-11

申请人PR Personal Care Laboratories
决定日期2026-06-11
产品代码NUC
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决定实质等同

器械摘要

PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) is the device name listed in this FDA 510(k) record. The listed applicant is PR Personal Care Laboratories. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K261292. 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 PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)?

PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is PR Personal Care Laboratories. The 510(k) number is K261292.

When did PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) receive FDA 510(k) clearance?

PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) received FDA 510(k) clearance on 2026-06-11, under 510(k) number K261292.

Who is the listed applicant for PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)?

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

What is the FDA product code for PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)?

The FDA product code for PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) is NUC.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：NUC）

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。

K260117EverslideSpecial Situations, LLCK253989HARU Orgasm 杰克·赫尔水基润滑剂（WL-OJ）；HARU Orgasm 水基润滑剂（WL-OR）；HARU STEAMY 水基润滑剂（WL-ST）Maxigen Biotech, Inc.K261905BUM油Bumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP水基个人润滑剂和保湿剂PINKSLIP, LLCK261909Plum Vagiceuticals® 阴道保湿栓PCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.

官方来源

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