Device class
Class II
Regulation 882.4800
Total clearances
3
2020-08-26 → 2022-05-13
Classification details
Medical specialty
Neurology
Regulation number
882.4800
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Thompson Surgical Instruments, Inc. |
1 |
0 |
2022-05-13 |
|
Minnetronix Neuro, Inc. |
1 |
0 |
2020-08-26 |
|
Vycor Medical, Inc. |
1 |
0 |
2021-01-14 |
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 |
| 61000 |
CPT
|
— |
Low
|
Percutaneous twist drill or burr hole(s) for evacuation of hematoma; retractors are ancillary surgical instruments |
| A4649 |
HCPCS
|
Surgical supply; miscellaneous ✓ CMS-verified description |
Low
|
Surgical supplies; self-retaining retractors may be billed as surgical instrument supplies |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2022-05-13 |
K210615 |
Thompson Surgical Instruments, Inc.
|
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) |
| 2021-01-14 |
K202694 |
Vycor Medical, Inc.
|
Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC) (together the VBAS Family) |
| 2020-08-26 |
K202072 |
Minnetronix Neuro, Inc.
|
MindsEye Expandable Port |