ESW · Prosthesis, Esophageal · Chrysalis Intelligence

Device class

Class II

Regulation 878.3610

Total clearances

2020-05-20 → 2026-07-10

Last 12 months

Unique sponsors

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.3610

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Taewoong Medical Co., Ltd.	4	1	2025-10-30
Boston Scientific	4	1	2026-07-10
M.I.Tech Co., Ltd.	4	1	2025-10-30
Merit Medical Systems, Inc.	1	0	2025-07-23
Thoracent, Inc.	1	0	2024-01-16

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
43284	CPT	—	Medium	Esophageal dilation; esophageal prosthesis placement is specialized and context-dependent
43305	CPT	—	Low	Esophageal foreign body removal; prosthesis may be billed with primary esophageal procedure

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-10	K261978	Boston Scientific Corporation	WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System
2025-10-30	K253327	M.I.Tech Co., Ltd.	HANAROSTENT Esophagus Upper (CCC)
2025-10-30	K243619	Taewoong Medical Co., Ltd.	Niti-S Esophageal Stent; Esophageal TTS Stent
2025-07-23	K251265	Merit Medical Systems, Inc.	Resilience Fully Covered Esophageal Stent System
2024-04-29	K233939	Boston Scientific	Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
2024-04-04	K233837	Boston Scientific Corporation	Agile Esophageal Stent System
2024-03-22	K240522	Taewoong Medical	Esophageal TTS Stent
2024-01-16	K223266	Thoracent, Inc.	Hilzo Esophageal Stents
2022-06-22	K221482	Taewoong Medical Co., Ltd.	Esophageal TTS Stent
2021-11-22	K211960	Boston Scientific Corporation	Agile Esophageal OTW Stent System
2021-11-18	K213251	M.I.Tech Co., Ltd.	HANAROSTENT Esophagus Asymmetric (CCC)
2021-10-08	K211706	Taewoong Medical Co., Ltd.	Esophageal TTS Stent
2021-07-23	K201160	M.I.Tech Co., Ltd.	HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
2020-05-20	K200860	M.I.Tech Co., Ltd.	HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)