510(k) Report

Devices descending from K101241

7 later devices reach Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203377VR101 Lubricating Intravaginal RingJ3 Bioscience, Inc.20210—
+1K170797wettrust D2careWettrust Korea Co., Ltd.20170—
+1K112217ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R) Long Lasting Vaginal…Polichem S.A20124—
+2K143349GynomunalPolichem S.A20151—
+2K132772Lubrigyn CreamUniderm Farmaceutici Srl20141—
+3K232040GynatrofTyros Biopharma, Inc.20240—
+3K150147Lubrigyn creamUniderm Farmaceutici Srl20150—