Cleared Special

K150573 - ebb Complete Tamponade System
(FDA 510(k) Clearance)

K150573 · Clinical Innovations, LLC · Obstetrics & Gynecology

Mar 2015

Decision

19d

Days

Class 2

Risk

K150573 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 March 25, 2015, 19 days after receiving the submission on March 6, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K150573 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 2015
Decision Date	March 25, 2015
Days to Decision	19 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