Device class
Class II
Regulation 884.4530
Total clearances
5
2020-08-28 → 2026-05-15
Definition
What is Intrauterine Tamponade Balloon
provides temporary control or reduction of postpartum uterine bleeding
Classification details
Medical specialty
Obstetrics/Gynecology
Regulation number
884.4530
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Alydia Health |
2 |
0 |
2021-09-30 |
|
Sinapi Biomedical (Pty) , Ltd. |
1 |
0 |
2023-11-13 |
|
Cook Incorporated
|
1 |
0 |
2022-10-28 |
|
Organon, LLC |
1 |
1 |
2026-05-15 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 59160 |
CPT
|
— |
High
|
Curettage, postpartum uterus; covers management of postpartum hemorrhage/intrauterine tamponade |
| A4070 |
HCPCS
|
— |
Medium
|
Lacrimal duct stent; may apply as reusable intrauterine device depending on design |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-05-15 |
K253642 |
Organon, LLC
|
Jada System (Jada-2002) |
| 2023-11-13 |
K230849 |
Sinapi Biomedical (Pty) , Ltd.
|
ELLAVI UBT |
| 2022-10-28 |
K223098 |
Cook Incorporated
|
Bakri Essential Postpartum Balloon |
| 2021-09-30 |
K212757 |
Alydia Health
|
Jada System |
| 2020-08-28 |
K201199 |
Alydia Health
|
Jada System |