Cleared Traditional

HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) (K200860) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200860 · M.I. Tech Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 2020
Decision
49d
Days
Class 2
Risk

K200860 is an FDA 510(k) clearance for the HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN). Classified as Prosthesis, Esophageal (product code ESW), Class II - Special Controls.

Submitted by M.I. Tech Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on May 20, 2020 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all M.I. Tech Co., Ltd. devices

Submission Details

510(k) Number K200860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2020
Decision Date May 20, 2020
Days to Decision 49 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
81d faster than avg
Panel avg: 130d · This submission: 49d
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 Consultant

Namsa
Beryl St. Jeanne

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ESW Prosthesis, Esophageal

All 32
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K200860.
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
Segmented Esophageal Stent System
K182910 · Micro-Tech (Nanjing) Co., Ltd. · May 2019
Agile Esophageal Stent System
K180144 · Boston Scientific Corporation · Sep 2018
Esophageal Stent System
K172813 · Micro-Tech (Nanjing) Co., Ltd. · May 2018