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FDA 510(k)

ONE PERSONAL LUBRICANT (SILICONE)

K-Number: K110690 · 2012-03-28

ApplicantOne
Decision Date2012-03-28
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ONE PERSONAL LUBRICANT (SILICONE) is the device name listed in this FDA 510(k) record. The listed applicant is One. It received FDA 510(k) clearance on 2012-03-28 under 510(k) number K110690. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE PERSONAL LUBRICANT (SILICONE)?

ONE PERSONAL LUBRICANT (SILICONE) is a medical device that received FDA 510(k) clearance on 2012-03-28. The listed applicant is One. The 510(k) number is K110690.

When did ONE PERSONAL LUBRICANT (SILICONE) receive FDA 510(k) clearance?

ONE PERSONAL LUBRICANT (SILICONE) received FDA 510(k) clearance on 2012-03-28, under 510(k) number K110690.

Who is the listed applicant for ONE PERSONAL LUBRICANT (SILICONE)?

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

What is the FDA product code for ONE PERSONAL LUBRICANT (SILICONE)?

The FDA product code for ONE PERSONAL LUBRICANT (SILICONE) is NUC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing One as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110691ONE PERSONAL LUBRICANT (WATER BASED)

Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260117EverslideSpecial Situations, LLCK253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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