Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT

K-Number: K040340 · 2004-04-28

ApplicantPersonal Products Company, Div. of Mcneil-Ppc, Inc.
Decision Date2004-04-28
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT is the device name listed in this FDA 510(k) record. The listed applicant is Personal Products Company, Div. of Mcneil-Ppc, Inc.. It received FDA 510(k) clearance on 2004-04-28 under 510(k) number K040340. 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 K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT?

K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT is a medical device that received FDA 510(k) clearance on 2004-04-28. The listed applicant is Personal Products Company, Div. of Mcneil-Ppc, Inc.. The 510(k) number is K040340.

When did K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT receive FDA 510(k) clearance?

K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT received FDA 510(k) clearance on 2004-04-28, under 510(k) number K040340.

Who is the listed applicant for K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT?

The FDA 510(k) record lists Personal Products Company, Div. of Mcneil-Ppc, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT?

The FDA product code for K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT 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 Personal Products Company, Div. of Mcneil-Ppc, Inc. 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.

K040164K-Y BRAND WARMING JELLY PERSONAL LUBRICANT

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.

↑