Device class
Class II
Regulation 876.5510
Total clearances
4
2020-02-25 → 2026-06-22
Definition
What is Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.5510
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Prodeon Medical, Inc.
|
2 |
2 |
2026-06-22 |
|
Medi-Tate , Ltd. |
2 |
0 |
2021-06-25 |
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 |
| 52275 |
CPT
|
— |
Medium
|
Transurethral resection of prostate; may apply depending on system mechanism |
| 52441 |
CPT
|
— |
Medium
|
Prostate urethral stent/device placement for BPH; applicable for temporary urethral systems |
Pulse
Most recent 510(k) clearances