Device class
—
Regulation —
Total clearances
3
2020-03-26 → 2025-02-19
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Sofradim Production
|
1 |
0 |
2024-02-13 |
|
Davol, Inc., A Subsidiary of C.R. Bard, Inc. |
1 |
0 |
2025-02-19 |
|
Novus Scientific AB |
1 |
0 |
2020-03-26 |
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 |
| 49560 |
CPT
|
— |
High
|
Repair initial inguinal hernia; open (includes umbilical hernia) |
| 49561 |
CPT
|
— |
High
|
Repair recurrent inguinal hernia; open |
| 49565 |
CPT
|
— |
Medium
|
Repair initial ventral/incisional hernia; open (includes umbilical hernia) |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
| 2025-02-19 |
K243241 |
Davol, Inc., A Subsidiary of C.R. Bard, Inc.
|
Phasix ST Umbilical Hernia Patch |
| 2024-02-13 |
K233661 |
Sofradim Production
|
Transorb Self-Gripping Resorbable Mesh |
| 2020-03-26 |
K191749 |
Novus Scientific AB
|
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh |