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FDA 510(k)

Passion Natural Water Based Lubricant

K-Number: K202017 · 2021-01-08

ApplicantXr, LLC
Decision Date2021-01-08
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Passion Natural Water Based Lubricant is a medical device manufactured by Xr, LLC. It received FDA 510(k) clearance on 2021-01-08 under approval number K202017. 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 Passion Natural Water Based Lubricant?

Passion Natural Water Based Lubricant is a medical device that received FDA 510(k) clearance on 2021-01-08. It is manufactured by Xr, LLC. The 510(k) number is K202017.

When was Passion Natural Water Based Lubricant approved by the FDA?

Passion Natural Water Based Lubricant received FDA 510(k) clearance on 2021-01-08, under approval number K202017.

What company makes Passion Natural Water Based Lubricant?

Passion Natural Water Based Lubricant is manufactured by Xr, LLC.

What is the FDA product code for Passion Natural Water Based Lubricant?

The FDA product code for Passion Natural Water Based Lubricant 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: 42026173 De novo chemo-optogenetics through the rational design of photoresponsive molecules and selection of their artificial protein binding pairs. Nature chemistry (2026) PMID: 41488933 A narrative review on the environmental impact of medicines: from water analysis and Frontiers in drug safety and regulation (2025)

Related Devices (Code: NUC)

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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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