Repagyn vaginal suppositories— 510(k) K153372

Substantially Equivalent

Farma-Derma S.R.L.

FDA 510(k) clearance K153372 for Repagyn vaginal suppositories, Substantially Equivalent on 2016-06-30. Applicant: Farma-Derma S.R.L..

Clearance details

Applicant: Farma-Derma S.R.L.
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2015-11-23
Decision date: 2016-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sala Bolognese, 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.