Cleared Special

ebb Complete Tamponade System

K153591 · Clinical Innovations, LLC · Obstetrics & Gynecology

Jan 2016

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K153591 is an FDA 510(k) clearance for the ebb Complete Tamponade System, a Intrauterine Tamponade Balloon (Class II — Special Controls, product code OQY), submitted by Clinical Innovations, LLC (Murray, US). The FDA issued a Cleared decision on January 14, 2016, 29 days after receiving the submission on December 16, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K153591 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2015
Decision Date	January 14, 2016
Days to Decision	29 days
Submission Type	Special
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