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FDA 510(k)

JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114

K-Number: K230674 · 2023-05-08

ApplicantCC Wellness, LLC
Decision Date2023-05-08
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 is a medical device manufactured by CC Wellness, LLC. It received FDA 510(k) clearance on 2023-05-08 under approval number K230674. 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 JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114?

JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 is a medical device that received FDA 510(k) clearance on 2023-05-08. It is manufactured by CC Wellness, LLC. The 510(k) number is K230674.

When was JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 approved by the FDA?

JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 received FDA 510(k) clearance on 2023-05-08, under approval number K230674.

What company makes JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114?

JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 is manufactured by CC Wellness, LLC.

What is the FDA product code for JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114?

The FDA product code for JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 is NUC.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 41804390 Modeling In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention with Acute Myocardial Infarction Complicated by Cardiogenic Shock Receiving Mechanical Circulatory Support. Medical devices (Auckland, N.Z.) (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 41488933 A narrative review on the environmental impact of medicines: from water analysis and Frontiers in drug safety and regulation (2025)

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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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