Cleared Special

Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component

K170622 · Cook Incorporated · Obstetrics & Gynecology
Mar 2017
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K170622 is an FDA 510(k) clearance for the Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component, a Intrauterine Tamponade Balloon (Class II — Special Controls, product code OQY), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on March 31, 2017, 30 days after receiving the submission on March 1, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K170622 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2017
Decision Date March 31, 2017
Days to Decision 30 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