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FDA 510(k)

X-Y Lubricating Jelly

K-Number: K220226 · 2023-03-28

ApplicantR&R Medical Corporation, Ltd.
Decision Date2023-03-28
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

X-Y Lubricating Jelly is a medical device manufactured by R&R Medical Corporation, Ltd.. It received FDA 510(k) clearance on 2023-03-28 under approval number K220226. 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 X-Y Lubricating Jelly?

X-Y Lubricating Jelly is a medical device that received FDA 510(k) clearance on 2023-03-28. It is manufactured by R&R Medical Corporation, Ltd.. The 510(k) number is K220226.

When was X-Y Lubricating Jelly approved by the FDA?

X-Y Lubricating Jelly received FDA 510(k) clearance on 2023-03-28, under approval number K220226.

What company makes X-Y Lubricating Jelly?

X-Y Lubricating Jelly is manufactured by R&R Medical Corporation, Ltd..

What is the FDA product code for X-Y Lubricating Jelly?

The FDA product code for X-Y Lubricating Jelly is 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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