K253642
- 510(k) number
- K253642
- Device name
- Jada System (Jada-2002)
- Applicant
- Organon, LLC NJ · US
- Product code
- OQY — Intrauterine Tamponade Balloon
- Decision date
- 2026-05-15
- Date received
- 2025-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253642.pdf
Official FDA record: K253642
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.