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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 the device name listed in this FDA 510(k) record. The listed applicant is R&R Medical Corporation, Ltd.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) 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. The listed applicant is R&R Medical Corporation, Ltd.. The 510(k) number is K220226.

When did X-Y Lubricating Jelly receive FDA 510(k) clearance?

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

Who is the listed applicant for X-Y Lubricating Jelly?

The FDA 510(k) record lists R&R Medical Corporation, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for X-Y Lubricating Jelly is NUC.

Other records listing R&R Medical Corporation, Ltd. 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.

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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.

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.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

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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