Cleared Traditional

K211960 - Agile Esophageal OTW Stent System

K211960 is the FDA 510(k) clearance for Agile Esophageal OTW Stent System by Boston Scientific Corporation. It is a Class 2 Gastroenterology & Urology device (product code ESW) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K211960 · Boston Scientific Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
151d
Days
Class 2
Risk

K211960 is an FDA 510(k) clearance for the Agile Esophageal OTW Stent System. Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on November 22, 2021 after a review of 151 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3610 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corporation devices

Submission Details

510(k) Number K211960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2021
Decision Date November 22, 2021
Days to Decision 151 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 130d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ESW Prosthesis, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3610
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - ESW Prosthesis, Esophageal

All 37
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K211960.
Esophageal TTS Stent
K240522 · Taewoong Medical · Mar 2024
Hilzo Esophageal Stents
K223266 · Thoracent, Inc. · Jan 2024
Esophageal TTS Stent
K221482 · Taewoong Medical Co., Ltd. · Jun 2022
HANAROSTENT Esophagus Asymmetric (CCC)
K213251 · M.I. Tech Co., Ltd. · Nov 2021
Esophageal TTS Stent
K211706 · Taewoong Medical Co., Ltd. · Oct 2021
HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
K201160 · M.I. Tech Co., Ltd. · Jul 2021