Device class
Class II
Regulation 882.4305
Total clearances
3
2022-06-20 → 2026-09-11
Classification details
Medical specialty
Neurology
Regulation number
882.4305
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Evonos GmbH & Co. KG |
1 |
0 |
2024-03-06 |
|
Guizhou Zirui Technology Co., Ltd. |
1 |
1 |
2026-09-11 |
|
Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. |
1 |
0 |
2022-06-20 |
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 |
| 20999 |
CPT
|
— |
Low
|
Compound powered burr/drill accessories typically part of stereotactic or bone removal |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-09-11 |
K254177 |
Guizhou Zirui Technology Co., Ltd.
|
Disposable Sterile Skull Drill (LZ) |
| 2024-03-06 |
K231403 |
Evonos GmbH & Co. KG
|
evoDrill Cranial Perforator |
| 2022-06-20 |
K213228 |
Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.
|
NeuroLine Disposable Cranial Perforator with Hudson end |