510(k) Report

Devices descending from K153372

4 later devices reach Repagyn vaginal suppositories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213220Revaree Plus Vaginal SuppositoriesFarma-Derma S.R.L.20223—
+2K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.20260—
+2K260007Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…Hudi Pharma Srl20260—
+2K230518HydraDose Vaginal SuppositoriesMD Labs, LLC20230—