OQY · Class II · 21 CFR 884.4530

FDA Product Code OQY: Intrauterine Tamponade Balloon

Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding

Leading manufacturers include Cook Incorporated.

1
Total
1
Cleared
28d
Avg days
2022
Since

List of Intrauterine Tamponade Balloon devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Intrauterine Tamponade Balloon devices (product code OQY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Obstetrics & Gynecology FDA review panel. Browse all Obstetrics & Gynecology devices →