Device class
Class II
Regulation 878.3300
Total clearances
3
2020-02-07 → 2024-10-18
Definition
What is Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
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 |
| 57288 |
CPT
|
— |
High
|
Sling procedure for stress urinary incontinence in female; transvaginal mini-sling surgical repair |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-10-18 |
K242473 |
Coloplast Corp.
|
Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) |
| 2023-02-15 |
K221874 |
Coloplast A/S
|
Altis Single Incision Sling System |
| 2020-02-07 |
K191416 |
Caldera Medical, Inc.
|
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack |