FDA 510(k)

Julva Velvé Water-Based Personal Lubricant

Número K: K254101 · 2026-04-16

Data da decisão2026-04-16

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Julva Velvé Water-Based Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Golden Isles Medical, Inc.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K254101. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Julva Velvé Water-Based Personal Lubricant?

Julva Velvé Water-Based Personal Lubricant is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Golden Isles Medical, Inc.. The 510(k) number is K254101.

When did Julva Velvé Water-Based Personal Lubricant receive FDA 510(k) clearance?

Julva Velvé Water-Based Personal Lubricant received FDA 510(k) clearance on 2026-04-16, under 510(k) number K254101.

Who is the listed applicant for Julva Velvé Water-Based Personal Lubricant?

The FDA 510(k) record lists Golden Isles Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Julva Velvé Water-Based Personal Lubricant?

The FDA product code for Julva Velvé Water-Based Personal Lubricant is NUC.

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