Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component— 510(k) K170622

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K170622 for Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component, Substantially Equivalent on 2017-03-31. Applicant: Cook Incorporated.

Clearance details

Applicant: Cook Incorporated
Product code: Code OQY
Advisory panel: Obstetrics/Gynecology
Date received: 2017-03-01
Decision date: 2017-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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.