Jada System (Jada-2002)— 510(k) K253642

Substantially Equivalent

Organon, LLC

FDA 510(k) clearance K253642 for Jada System (Jada-2002), Substantially Equivalent on 2026-05-15. Applicant: Organon, LLC.

Clearance details

Applicant: Organon, LLC
Product code: Code OQY
Advisory panel: Obstetrics/Gynecology
Date received: 2025-11-19
Decision date: 2026-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jersey City, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OQY

product code OQY

Death: 8
Injury: 616
Malfunction: 500
Total: 1,124

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.