Device class
Class II
Regulation 878.3300
Total clearances
3
2021-12-20 → 2024-11-15
Definition
What is Mesh, Surgical, For Stress Urinary Incontinence, Male
surgical treatment of male stress urinary incontinence post-prostatectomy
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.3300
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 |
| 53440 |
CPT
|
— |
High
|
Urethral suspension fix for stress incontinence; OTM is surgical mesh for male post-prostatectomy stress incontinence |
| 53444 |
CPT
|
— |
Medium
|
Male urethral sling procedure for incontinence; alternative surgical approach |
Pulse
Most recent 510(k) clearances