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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceJuveena Hydrogel System
Generic NameBarrier, absorbable, adhesion
ApplicantRejoni, Inc.
201 Burlington Rd.
North Bldg., Second Floor
Bedford, MA 01730
PMA NumberP250051
Date Received12/10/2025
Decision Date09/28/2026
Product Code MCN 
Advisory Committee Obstetrics/Gynecology
Clinical TrialsNCT05394662
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for Juveena® Hydrogel System. The Juveena® Hydrogel System is indicated for use in adult women to reduce the incidence and severity of intrauterine adhesion formation following hysteroscopic adhesiolysis for symptomatic moderate to severe intrauterine adhesions.The Rejoni Acorn Catheter is indicated to access the uterine cavity and deliver the Juveena® Hydrogel solution into the uterine cavity.
Post-Approval StudyShow Report Schedule and Study Progress
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