Cleared Traditional

Every Second Matters-Uterine Balloon Tamponade (?ESM-UBT?)

K191264 · Ujenzi Charitable Trust · Obstetrics & Gynecology

Oct 2019

Decision

173d

Days

Class 2

Risk

About This 510(k) Submission

K191264 is an FDA 510(k) clearance for the Every Second Matters-Uterine Balloon Tamponade (?ESM-UBT?), a Intrauterine Tamponade Balloon (Class II — Special Controls, product code OQY), submitted by Ujenzi Charitable Trust (Medford, US). The FDA issued a Cleared decision on October 30, 2019, 173 days after receiving the submission on May 10, 2019. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K191264 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2019
Decision Date	October 30, 2019
Days to Decision	173 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	OQY — Intrauterine Tamponade Balloon
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.4530
Definition	Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding