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FDA 510(k)

K-Y BRAND SENSUAL MIST

K-Number: K053397 · 2006-02-17

ApplicantMcneil-Ppc, Inc.
Decision Date2006-02-17
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

K-Y BRAND SENSUAL MIST is the device name listed in this FDA 510(k) record. The listed applicant is Mcneil-Ppc, Inc.. It received FDA 510(k) clearance on 2006-02-17 under 510(k) number K053397. 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 SENSUAL MIST?

K-Y BRAND SENSUAL MIST is a medical device that received FDA 510(k) clearance on 2006-02-17. The listed applicant is Mcneil-Ppc, Inc.. The 510(k) number is K053397.

When did K-Y BRAND SENSUAL MIST receive FDA 510(k) clearance?

K-Y BRAND SENSUAL MIST received FDA 510(k) clearance on 2006-02-17, under 510(k) number K053397.

Who is the listed applicant for K-Y BRAND SENSUAL MIST?

The FDA 510(k) record lists 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 SENSUAL MIST?

The FDA product code for K-Y BRAND SENSUAL MIST 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 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.

K081236K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREMEK072421K-Y BRAND YOURS+MINEK072360K-Y BRAND INTRIGUE INTENSE WARMING SENSATIONK062535K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLINGK023789O.B. TAMPONS

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

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

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