HyaloGYN Vaginal Hydrating Gel

FDA 510(k) K150883 · Fidia Farmaceutici S.P.A.

Substantially Equivalent

510(k) numberK150883

Submission

Device name
HyaloGYN Vaginal Hydrating Gel
Applicant
Fidia Farmaceutici S.P.A.
Abano Terme, IT
Received
April 2, 2015
Decision date
September 1, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUC – Lubricant, Personal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5300
Specialty
Obstetrics/Gynecology

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

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Questions and answers

When was HyaloGYN Vaginal Hydrating Gel cleared by the FDA?

HyaloGYN Vaginal Hydrating Gel (K150883) received a 510(k) decision of Substantially Equivalent on September 1, 2015, 152 days after the submission was received.

What is the product code of K150883?

The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.