OQY

Intrauterine Tamponade Balloon

Product code

OQY

Device name

Intrauterine Tamponade Balloon

Device class

Class 2

21 CFR

21 CFR 884.4530

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

11 (all years; only the last 3 years are listed here)

FDA classification definition

provides temporary control or reduction of postpartum uterine bleeding

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-05-15.

2 summaries are archived here for direct download.