Device class
Class II
Regulation 878.3610
Total clearances
3
2020-04-17 → 2024-03-08
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.3610
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 |
| 45398 |
CPT
|
— |
High
|
Standard code for colonoscopic placement of expandable metallic stent |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-03-08 |
K234046 |
Boston Scientific Corporation
|
WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System |
| 2020-08-17 |
K201159 |
Boston Scientific Corporation
|
WallFlex Colonic Stent System with Anchor Lock Delivery System |
| 2020-04-17 |
K200257 |
Boston Scientific Corporation
|
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System |