Cleared Special

HANAROSTENT Esophagus Asymmetric (CCC) (K213251) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K213251 · M.I. Tech Co., Ltd. · Gastroenterology & Urology device
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Nov 2021
Decision
49d
Days
Class 2
Risk

K213251 is an FDA 510(k) clearance for the HANAROSTENT Esophagus Asymmetric (CCC). 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 November 18, 2021 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

Submission Details

510(k) Number K213251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2021
Decision Date November 18, 2021
Days to Decision 49 days
Submission Type Special
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
Modification to existing cleared device.

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 32
Devices cleared under the same product code (ESW) and FDA review panel - the closest regulatory comparables to K213251.
Hilzo Esophageal Stents
K223266 · Thoracent, Inc. · Jan 2024
Esophageal TTS Stent
K221482 · Taewoong Medical Co., Ltd. · Jun 2022
Agile Esophageal OTW Stent System
K211960 · Boston Scientific Corporation · 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
HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
K200860 · M.I. Tech Co., Ltd. · May 2020