Device class
Class II
Regulation 876.1500
Total clearances
7
2020-01-30 → 2024-07-03
Definition
What is Submucosal Injection Agent
Intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.
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 removal of tumor, polyp, or other lesion by snare technique; submucosal injection agent standard adjunct |
| 45384 |
CPT
|
— |
High
|
Colonoscopy with removal of tumor, polyp by snare; submucosal lift agent used |
Pulse
Most recent 510(k) clearances