Device class
Class II
Regulation 878.4300
Total clearances
3
2021-02-24 → 2023-11-09
Definition
What is Temporary Tissue Marker
To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4300
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 |
| A4648 |
HCPCS
|
Tissue marker, implantable, any type, each ✓ CMS-verified description |
Medium
|
Tissue marker/localization device for surgical guidance |
Pulse
Most recent 510(k) clearances