Device class
Class II
Regulation 874.4710
Total clearances
7
2020-01-24 → 2024-01-19
Definition
What is Esophagoscope (Flexible Or Rigid)
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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
Ear, Nose, Throat
Regulation number
874.4710
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 |
| 43191 |
CPT
|
— |
High
|
Esophagoscopy, flexible, diagnostic; standard code for esophagoscopy |
| 43197 |
CPT
|
— |
Medium
|
Esophagoscopy with biopsy; if tissue sampling performed |
Pulse
Most recent 510(k) clearances