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Hyalo GYN Vaginal Hydrating Gel - Made without Parabens

Model 179704 · FIDIA FARMACEUTICI SPA · DI M7131797040

NUC — Lubricant, Personal · Class II · 21 CFR 884.5300

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

11222019-05: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 2/device05070701
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0501
2019-0701
2023-0702
2025-0102
This device (reports/month)Average device in NUC (reports/device/month)

Regulatory clearances

  • K150883 SESE 2015-09-01 (k number procode)

Predicate lineage

K150883 — cites (transitively): K070587 (d1), K094039 (d1), K101098 (d1), K072647 (d2), K062682 (d2) — cited as predicate by K191052, K200098, K211998

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — FIDIA FARMACEUTICI SPA

  • VAI 2016-11-10 Fidia Farmaceutici S.p.A. · 1 citations
  • NAI 2014-11-14 Fidia Farmaceutici S.p.A. · 0 citations
  • NAI 2010-12-15 Fidia Farmaceutici S.p.A. · 0 citations