510(k) · Cleared
ClearedHANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
M.I.Tech Co., Ltd. · ESW Prosthesis, Esophageal
Cleared on Jul 23, 2021 as substantially equivalent to K172813 (Micro-Tech (Nanjing) Co., Ltd., 2018) after a 449-day review. Its family tree reaches back 6 generations to 1995. 2 later devices descend from it.
- Decided
- Jul 23, 2021
- Review
- 449 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K925406 (1995). 18 ancestors in all, the oldest K940838 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK925406 Biliary Endoprostheses W/Unistep Delivery SystemSchneider Intl., Ltd. · 1995
- 5 generations backK962899 Ultraflex DiamondBoston Scientific Corp · 1997
- 4 generations backK012883 Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent…Boston Scientific Corp · 2001 · Recalled
- 3 generations backK073266 Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008
- 2 generations backK091510 Wallflex Esophageal Fully Covered Stent System, Models M00516700…Boston Scientific Corporation · 2009
- 1 generation backK172813 Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2018
- This deviceK201160 HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK253327 HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK213251 HANAROSTENT Esophagus Asymmetric (CCC)M.I.Tech Co., Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K925406 | Biliary Endoprostheses W/Unistep Delivery System | Schneider Intl., Ltd. | 1995 | — |
| −5 | K962899 | Ultraflex Diamond | Boston Scientific Corp | 1997 | — |
| −4 | K012883 | Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System… | Boston Scientific Corp | 2001 | 46 |
| −3 | K073266 | Wallflex Partially Covered Esophageal Stent System | Boston Scientific Corp | 2008 | — |
| −2 | K091510 | Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710… | Boston Scientific Corporation | 2009 | — |
| −1 | K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
| 0 (this device) | K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | 2021 | — |
| +1 | K253327 | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | 2025 | — |
| +1 | K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ESW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ESW device
- #1 K261978 WallFlex Esophageal Stent System;Agile…score 15.2 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K172813 | Esophageal Stent SystemSummary page 5…phageal Stent System Applicant: Micro-Tech (Nanjing) Co., Ltd. 510(k) Number: K172813 Clearance Date: June 21, 2018 Device:… | 2018 |
| † | K111611 | Endomaxx Fully Covered Esophageal Stent | 2011 |
| † | K091510 | Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K253327 (M.I.Tech Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · ESW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ESW
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ESW
25in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ESW
120in 2025
MAUDE reports naming product code ESW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 88 |
| 2008 | 5 | 99 | 0 | 153 |
| 2009 | 3 | 35 | 0 | 239 |
| 2010 | 3 | 206 | 25 | 255 |
| 2011 | 1 | — | 0 | 140 |
| 2012 | 2 | — | 0 | 121 |
| 2013 | 2 | — | 0 | 145 |
| 2014 | 0 | — | 0 | 169 |
| 2015 | 0 | — | 0 | 175 |
| 2016 | 1 | — | 0 | 153 |
| 2017 | 0 | — | 0 | 87 |
| 2018 | 2 | — | 0 | 86 |
| 2019 | 1 | — | 0 | 167 |
| 2020 | 1 | — | 0 | 155 |
| 2021 | 4 | 139 | 0 | 77 |
| 2022 | 1 | — | 0 | 109 |
| 2023 | 0 | — | 0 | 155 |
| 2024 | 4 | 130 | 0 | 166 |
| 2025 | 3 | 90 | 0 | 120 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The HANAROSTENT® Esophagus (CCC) and the HANAROSTENT® Esophagus (NCN) are intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201160: HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201160
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026