Atlas FDA

Agile Esophageal Stent System

FDA 510(k) clearance K180144 · decided 2018-09-21

Clearance details

K-number
K180144
Device name
Agile Esophageal Stent System
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2018-01-18
Decision date
2018-09-21
Days to decision
246 days
Clearance type
Traditional
Product code
ESW
Device class
2
Regulation number
878.3610
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (K261978)Boston Scientific Corporation2026-07-10
Niti-S Esophageal Stent; Esophageal TTS Stent (K243619)Taewoong Medical Co., Ltd.2025-10-30
HANAROSTENT Esophagus Upper (CCC) (K253327)M.I.Tech Co., Ltd.2025-10-30
Resilience Fully Covered Esophageal Stent System (K251265)Merit Medical Systems, Inc.2025-07-23
Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (K233939)Boston Scientific2024-04-29
Agile Esophageal Stent System (K233837)Boston Scientific Corporation2024-04-04
Esophageal TTS Stent (K240522)Taewoong Medical2024-03-22
Hilzo Esophageal Stents (K223266)Thoracent, Inc.2024-01-16
Esophageal TTS Stent (K221482)Taewoong Medical Co., Ltd.2022-06-22
Agile Esophageal OTW Stent System (K211960)Boston Scientific Corporation2021-11-22
HANAROSTENT Esophagus Asymmetric (CCC) (K213251)M.I.Tech Co., Ltd.2021-11-18
Esophageal TTS Stent (K211706)Taewoong Medical Co., Ltd.2021-10-08

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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