Cleared Traditional

K201160 - HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) (FDA 510(k) Clearance)

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

K201160 · M.I. Tech Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jul 2021
Decision
449d
Days
Class 2
Risk

K201160 is an FDA 510(k) clearance for the HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (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 July 23, 2021 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

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

Submission Details

510(k) Number K201160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2020
Decision Date July 23, 2021
Days to Decision 449 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
319d slower than avg
Panel avg: 130d · This submission: 449d
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
Heidi Busz

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 58
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K201160.
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Ultraflex Esophageal NG Stent System
K233939 · Boston Scientific · Apr 2024
Agile Esophageal Stent System
K233837 · Boston Scientific Corporation · Apr 2024
Esophageal TTS Stent
K240522 · Taewoong Medical · Mar 2024