HyaloGYN Vaginal Moisturizing Suppositories— 510(k) K191052

Substantially Equivalent

Fidia Farmaceutici S.P.A.

FDA 510(k) clearance K191052 for HyaloGYN Vaginal Moisturizing Suppositories, Substantially Equivalent on 2020-01-09. Applicant: Fidia Farmaceutici S.P.A..

Clearance details

Applicant: Fidia Farmaceutici S.P.A.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2019-04-19
Decision date: 2020-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abano Terme, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.