Class Class II

Coconut Hybrid (K242162)

K242162 2024-09-19 Traditional
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Description

Coconut Hybrid by Good Clean Love, Inc., an FDA 510(k) cleared obstetrics/gynecology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242162
Clearance Date2024-09-19
Clearance TypeTraditional
Product CodeNUC
Regulation Number884.5300

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Predicate lineage for K242162

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. Coconut Hybrid (K242162) 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
K180712Coconut Infused Hybrid Personal LubricantUnited Consortium2018

Trace the full predicate network for K242162

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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