Device class
Class II
Regulation 876.1500
Total clearances
4
2021-01-06 → 2025-10-09
Definition
What is Anoscope And Accessories
To examine and perform procedures within the anus and rectum.
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.1500
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Gastro Concepts, LLC |
1 |
0 |
2024-12-13 |
|
Well Care (Wuhan) Medical Technology Co., Ltd. |
1 |
0 |
2023-12-22 |
|
Haemoband Surgical, Ltd. |
1 |
1 |
2025-10-09 |
|
Applied Medical Resources
|
1 |
0 |
2021-01-06 |
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 |
| 46600 |
CPT
|
— |
High
|
Anoscopy with or without inspection, biopsy, or removal of tissue |
| 46604 |
CPT
|
— |
High
|
Anoscopy with removal of lesion |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-10-09 |
K250645 |
Haemoband Surgical, Ltd.
|
SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) |
| 2024-12-13 |
K242668 |
Gastro Concepts, LLC
|
Gastro Concepts Air Assist |
| 2023-12-22 |
K230439 |
Well Care (Wuhan) Medical Technology Co., Ltd.
|
WellCare Anoscope |
| 2021-01-06 |
K200021 |
Applied Medical Resources
|
Applied Medical Anoscope |