Device class
Class II
Regulation 876.1500
Total clearances
7
2020-01-31 → 2026-05-01
Definition
What is Enteroscope And Accessories
To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification details
Medical specialty
Gastroenterology, Urology
Regulation number
876.1500
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 |
| 43235 |
CPT
|
— |
High
|
EGD with biopsy is standard, but enteroscope is specialized; 44360-44363 for small bowel endoscopy more accurate |
| 44360 |
CPT
|
— |
High
|
Endoscopy of small intestine for diagnostic purposes |
| 44361 |
CPT
|
— |
Medium
|
Small bowel endoscopy with biopsy |
Pulse
Most recent 510(k) clearances