Class Class II

Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine (K213892)

K213892 2023-03-07 Traditional
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Description

Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine by Rb Health (Us), LLC, an FDA 510(k) cleared obstetrics/gynecology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK213892
Clearance Date2023-03-07
Clearance TypeTraditional
Product CodeNUC
Regulation Number884.5300

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Predicate lineage for K213892

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine (K213892) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K150153Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Wa...Package Solutions, LLC2015

Trace the full predicate network for K213892

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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