FDA 510(k)

Jada System

K-Number: K201199 · 2020-08-28

Decision Date2020-08-28

Product CodeOQY

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Jada System is the device name listed in this FDA 510(k) record. The listed applicant is Alydia Health. It received FDA 510(k) clearance on 2020-08-28 under 510(k) number K201199. 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 System is a medical device that received FDA 510(k) clearance on 2020-08-28. The listed applicant is Alydia Health. The 510(k) number is K201199.

When did Jada System receive FDA 510(k) clearance?

Jada System received FDA 510(k) clearance on 2020-08-28, under 510(k) number K201199.

Who is the listed applicant for Jada System?

The FDA 510(k) record lists Alydia Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Jada System?

The FDA product code for Jada System is OQY.

Other records listing Alydia Health as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212757Jada System

Related Devices (Code: OQY)

K253642Jada System (Jada-2002)Organon, LLC K230849ELLAVI UBTSinapi Biomedical (Pty) , Ltd.K223098Bakri Essential Postpartum BalloonCook Incorporated K212757Jada SystemAlydia Health K191264Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)Ujenzi Charitable Trust K170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentCook Incorporated

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.