Device class
Class II
Regulation 882.1350
Total clearances
4
2020-05-27 → 2024-12-11
Classification details
Medical specialty
Neurology
Regulation number
882.1350
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 |
| 95813 |
CPT
|
— |
High
|
EEG with needle electrodes; needle electrodes are used in specialized EEG/EMG procedures |
| A4556 |
HCPCS
|
Electrodes, (e.g., apnea monitor), per pair ✓ CMS-verified description |
Medium
|
Electrode/transducer for use with EEG/EMG; supply code for needle electrode materials |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-12-11 |
K241045 |
Technomed Europe
|
Disposable Subdermal Needle Electrode, Corkscrew |
| 2023-12-04 |
K232581 |
Suzhou Haishen Medical Device Associates Co., Ltd.
|
Medical Disposable Sterile Needle Electrode |
| 2023-06-29 |
K231691 |
TeDan Surgical Innovations, Inc.
|
Phantom XL Insulated Dilators |
| 2020-05-27 |
K200984 |
Rhythmlink International, LLC
|
Guardian Needle Electrode |