DeviceClearance

Product code OQY— Obstetrics/Gynecology

Jada System

Classification name
Intrauterine Tamponade Balloon
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Total cleared
11
First cleared
Most recent

FDA classification definition

“provides temporary control or reduction of postpartum uterine bleeding”

— U.S. Food and Drug Administration, device classification record for product code OQY under 21 CFR 884.4530, via openFDA

Market context for product code OQY

FDA has cleared 11 devices under product code OQY between 2010 and 2026, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OQY

Adverse events under product code OQY

product code OQY
Death
8
Injury
616
Malfunction
500
Total
1,124

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

Recent clearances under product code OQY

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