Cleared Special

Bakri Essential Postpartum Balloon

K223098 · Cook Incorporated · Obstetrics & Gynecology

Oct 2022

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K223098 is an FDA 510(k) clearance for the Bakri Essential Postpartum Balloon, a Intrauterine Tamponade Balloon (Class II — Special Controls, product code OQY), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on October 28, 2022, 28 days after receiving the submission on September 30, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K223098 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2022
Decision Date	October 28, 2022
Days to Decision	28 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