Device class
Class II
Regulation 876.4340
Total clearances
7
2020-09-16 → 2025-11-19
Definition
What is High Intensity Ultrasound System For Prostate Tissue Ablation
Prostate tissue ablation
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.4340
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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 |
| 55873 |
CPT
|
— |
High
|
Transurethral microwave thermotherapy of prostate; high-intensity ultrasound ablation has similar billing intent |
| 55875 |
CPT
|
— |
Medium
|
Transurethral radiofrequency thermotherapy of prostate; thermal ablation procedural analog |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-11-19 |
K251910 |
Edap Technomed, Inc.
|
Focal One® |
| 2024-05-09 |
K240296 |
Profound Medical, Inc.
|
Tulsa Pro System (Pad-105) |
| 2023-10-30 |
K231378 |
Insightec, Ltd.
|
Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 |
| 2023-09-20 |
K230692 |
Profound Medical, Inc.
|
TULSA-PRO System |
| 2022-09-06 |
K211858 |
Profound Medical, Inc.
|
TULSA-PRO System |
| 2021-11-23 |
K212150 |
Insightec, Inc.
|
Exablate Prostate System |
| 2020-09-16 |
K202286 |
Profound Medical, Inc.
|
Tulsa-Pro System |