510(k) · Cleared
ClearedBiliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Tech (Nanjing) Co., Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Sep 6, 2023 as substantially equivalent to K172044 (Cook Ireland, Ltd., 2018) after a 232-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Sep 6, 2023
- Review
- 232 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K851962 (1985). No later device cites it as a predicate yet.
- Root · 3 generations backK851962 Zimmon Biliary Stent SetWilson-Cook Medical, Inc. · 1985 · Recalled
- 2 generations backK040151 Oasis Biliary Stent Introduction SystemWilson-Cook Medical, Inc. · 2004
- 1 generation backK172044 Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung…Cook Ireland, Ltd. · 2018
- This deviceK230127 Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary…Micro-Tech (Nanjing) Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851962 | Zimmon Biliary Stent Set | Wilson-Cook Medical, Inc. | 1985 | 5 |
| −2 | K040151 | Oasis Biliary Stent Introduction System | Wilson-Cook Medical, Inc. | 2004 | — |
| −1 | K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex… | Cook Ireland, Ltd. | 2018 | — |
| 0 (this device) | K230127 | Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent… | Micro-Tech (Nanjing) Co., Ltd. | 2023 | — |
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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 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 |
|---|---|---|---|
| * | K172044 | Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary…Summary page 7…device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device cleared under K172044. Comparison to predicate Devices: Proposed Device Predicate Device Item i ) Remark Biliary Plastic Stent Set (K172044) Product… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 38 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K172044.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The Biliary Plastic Stent is used to drain obstructed biliary ducts.
The Biliary Plastic Stent Introducer is used for endoscopic biliary stent placement.
The Biliary Plastic Stent Introducer/ short-wire compatible is used for endoscopic biliary stent placement.
The Biliary Plastic Stent Set is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
The Biliary Plastic Stent Set/ short-wire compatible is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K230127 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230127: Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230127
Report an extraction error
Are you the manufacturer?
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