Ellavi Ubt

FDA 510(k) K230849 · Sinapi Biomedical (Pty) , Ltd.

Substantially Equivalent

510(k) numberK230849

Submission

Device name
Ellavi Ubt
Applicant
Sinapi Biomedical (Pty) , Ltd.
Stellenbosch, ZA
Received
March 28, 2023
Decision date
November 13, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OQY – Intrauterine Tamponade Balloon
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Specialty
Obstetrics/Gynecology

provides temporary control or reduction of postpartum uterine bleeding

Other 510(k)s with product code OQY

510(k)DeviceApplicantDecision
K253642Jada System (Jada-2002)OQY · Traditional Organon, LLC05/15/2026SE
K223098Bakri Essential Postpartum BalloonOQY · Special Cook Incorporated10/28/2022SE
K212757Jada SystemOQY · Special Alydia Health09/30/2021SE
K201199Jada SystemOQY · Traditional Alydia Health08/28/2020SE
K191264Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)OQY · Traditional Ujenzi Charitable Trust10/30/2019SE
K170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentOQY · Special Cook Incorporated03/31/2017SE
K153591ebb Complete Tamponade SystemOQY · Special Clinical Innovations, LLC01/14/2016SE
K150573ebb Complete Tamponade SystemOQY · Special Clinical Innovations, LLC03/25/2015SE
K101535Bt-CathOQY · Traditional Utah Medical Products, Inc.01/11/2011SE
K091958Belfort-Dildy Obstetric Tamponade SystemOQY · Traditional Glenveigh Surgical, LLC04/30/2010SE

Questions and answers

When was Ellavi Ubt cleared by the FDA?

Ellavi Ubt (K230849) received a 510(k) decision of Substantially Equivalent on November 13, 2023, 230 days after the submission was received.

What is the product code of K230849?

The FDA product code is OQY – Intrauterine Tamponade Balloon, a Class II (moderate risk) device regulated under 21 CFR 884.4530.