Device class
Class II
Regulation 878.4370
Total clearances
4
2020-04-26 → 2023-10-25
Definition
What is Drape, Surgical, Antimicrobial
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4370
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Controlrad, Inc.
|
1 |
0 |
2020-04-26 |
|
Avery Dennison Belgie Bvba |
1 |
0 |
2021-07-30 |
|
Avery Dennison Medical , Ltd. |
1 |
0 |
2023-10-25 |
|
3M Company
|
1 |
0 |
2023-05-18 |
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 |
| A4648 |
HCPCS
|
Tissue marker, implantable, any type, each ✓ CMS-verified description |
High
|
Standard HCPCS code for surgical drapes |
| A4649 |
HCPCS
|
Surgical supply; miscellaneous ✓ CMS-verified description |
Medium
|
HCPCS code for sterile surgical drapes |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2023-10-25 |
K230645 |
Avery Dennison Medical , Ltd.
|
BeneHold Surgical Incise Drape with CHG antimicrobial II |
| 2023-05-18 |
K222578 |
3M Company
|
3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) |
| 2021-07-30 |
K202208 |
Avery Dennison Belgie Bvba
|
BeneHold Surgical Incise Drape with CHG antimicrobial |
| 2020-04-26 |
K200238 |
Controlrad, Inc.
|
ControlRad Sterile Cover |