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FDA 510(k)

HyaloGYN Vaginal Moisturizing Suppositories

K-Number: K191052 · 2020-01-09

ApplicantFidia Farmaceutici S.P.A.
Decision Date2020-01-09
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HyaloGYN Vaginal Moisturizing Suppositories is the device name listed in this FDA 510(k) record. The listed applicant is Fidia Farmaceutici S.P.A.. It received FDA 510(k) clearance on 2020-01-09 under 510(k) 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. The listed applicant is Fidia Farmaceutici S.P.A.. The 510(k) number is K191052.

When did HyaloGYN Vaginal Moisturizing Suppositories receive FDA 510(k) clearance?

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

Who is the listed applicant for HyaloGYN Vaginal Moisturizing Suppositories?

The FDA 510(k) record lists Fidia Farmaceutici S.P.A. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Fidia Farmaceutici S.P.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P950027Acid, hyaluronic, intraarticularPMA P180040Acid, hyaluronic, intraarticular

Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

Official Source

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

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