Device class
Class II
Regulation 878.4683
Total clearances
8
2020-05-04 → 2025-05-15
Definition
What is Negative Pressure Wound Therapy Non-Powered Suction Apparatus
A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4683
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Guard Medical, Inc.
|
7 |
0 |
2025-05-15 |
|
Benq Materials Corporation |
1 |
0 |
2020-05-04 |
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 |
| 97605 |
CPT
|
— |
High
|
Negative pressure wound therapy without electrical pump; non-powered suction apparatus standard code |
| E2402 |
HCPCS
|
Negative pressure wound therapy electrical pump, stationary or portable ✓ CMS-verified description |
Medium
|
Negative pressure wound therapy dressing supply code often paired with CPT service |
Pulse
Most recent 510(k) clearances