FDA 510(k)

HyaloGYN Vaginal Moisturizing Suppositories

K-Number: K191052 · 2020-01-09

Decision Date2020-01-09

Product CodeNUC

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

HyaloGYN Vaginal Moisturizing Suppositories is a medical device manufactured by Fidia Farmaceutici S.P.A.. It received FDA 510(k) clearance on 2020-01-09 under approval number K191052. 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 HyaloGYN Vaginal Moisturizing Suppositories?

HyaloGYN Vaginal Moisturizing Suppositories is a medical device that received FDA 510(k) clearance on 2020-01-09. It is manufactured by Fidia Farmaceutici S.P.A.. The 510(k) number is K191052.

When was HyaloGYN Vaginal Moisturizing Suppositories approved by the FDA?

HyaloGYN Vaginal Moisturizing Suppositories received FDA 510(k) clearance on 2020-01-09, under approval number K191052.

What company makes HyaloGYN Vaginal Moisturizing Suppositories?

HyaloGYN Vaginal Moisturizing Suppositories is manufactured by Fidia Farmaceutici S.P.A..

What is the FDA product code for HyaloGYN Vaginal Moisturizing Suppositories?

The FDA product code for HyaloGYN Vaginal Moisturizing Suppositories is NUC.

Other Devices by Fidia Farmaceutici S.P.A.

PMA P950027Acid, hyaluronic, intraarticular PMA P180040Acid, hyaluronic, intraarticular

Related Devices (Code: NUC)

K161585Mano and Mano Personal LubricantMano and Mano Proprietary Limited K161544Trojan Chain Reaction Personal LubricantChurch & Dwight Co., Inc. K161385Just Like Me Personal LubricantWtfn-Dba Classic Erotica/Holiday Products K152671Pulse Aloe-ahhToaster Labs, Inc. K152628Pulse H20h!Toaster Labs, Inc. K153372Repagyn vaginal suppositoriesFarma-Derma S.R.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.