Device class
Class II
Regulation 878.3300
Total clearances
3
2020-03-26 → 2025-02-19
Definition
What is Mesh, Surgical, Absorbable, Abdominal Hernia
For reinforcement of soft tissue where weakness exists during hernia repair.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.3300
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 |