FDA Product Code OQY: Intrauterine Tamponade Balloon
Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding
Leading manufacturers include Cook Incorporated and Sinapi Biomedical (Pty) , Ltd..
10
Total
10
Cleared
118d
Avg days
2010
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Intrauterine Tamponade Balloon Devices (Product Code OQY)
10 devices
Cleared
Nov 13, 2023
ELLAVI UBT
Sinapi Biomedical (Pty) , Ltd.
Obstetrics & Gynecology
230d
Cleared
Oct 28, 2022
Bakri Essential Postpartum Balloon
Cook Incorporated
Obstetrics & Gynecology
28d
About Product Code OQY - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code OQY since 2010, with 10 receiving FDA clearance (average review time: 118 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
OQY devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →