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FDA 510(k)

Jada System (Jada-2002)

K-Number: K253642 · 2026-05-15

ApplicantOrganon, LLC
Decision Date2026-05-15
Product CodeOQY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Jada System (Jada-2002) is a medical device manufactured by Organon, LLC. It received FDA 510(k) clearance on 2026-05-15 under approval number K253642. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Jada System (Jada-2002)?

Jada System (Jada-2002) is a medical device that received FDA 510(k) clearance on 2026-05-15. It is manufactured by Organon, LLC. The 510(k) number is K253642.

When was Jada System (Jada-2002) approved by the FDA?

Jada System (Jada-2002) received FDA 510(k) clearance on 2026-05-15, under approval number K253642.

What company makes Jada System (Jada-2002)?

Jada System (Jada-2002) is manufactured by Organon, LLC.

What is the FDA product code for Jada System (Jada-2002)?

The FDA product code for Jada System (Jada-2002) is OQY.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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