Device class
Class II
Regulation 878.4961
Total clearances
8
2021-02-26 → 2025-07-08
Definition
What is Mountable Electromechanical Surgical System For Transluminal Approaches
A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4961
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 |
| 43289 |
CPT
|
— |
Medium
|
Endoscopic ultrasound (EUS) guided transesophageal needle aspiration, biopsy, or radiofrequency ablation |
| 43292 |
CPT
|
— |
Medium
|
Endoscopic ultrasound-guided transesophageal needle aspiration/biopsy of the esophagus or posterior mediastinum or upper GI tract |
| 99455 |
CPT
|
— |
Low
|
Electrocardiogram; routine with at least 12 leads interpretation and report |
Pulse
Most recent 510(k) clearances