Bakri Essential Postpartum Balloon— 510(k) K223098

Name: FDA 510(k) clearance K223098
Creator: U.S. Food and Drug Administration
Published: 2022-10-28

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K223098 for Bakri Essential Postpartum Balloon, Substantially Equivalent on 2022-10-28. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code OQY
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2022-09-30
Decision date: 2022-10-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OQY

product code OQY

Death: 8
Injury: 616
Malfunction: 500
Total: 1,124

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.