FDA product code FGE: Stents, Drains And Dilators For The Biliary Ducts
FGE is the FDA product code for stents, drains and dilators for the biliary ducts. It is a Class II device, regulated under 21 CFR 876.5010 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 478 510(k) submissions under FGE, 33 in the last five years, from 144 different applicants. The average 510(k) review took 127 days (median 84); 191 days on average over the last three years. FDA has posted 451 recalls for FGE devices, 74 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class II |
| Regulation | 21 CFR 876.5010 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for FGE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 75 |
| 2018 | 7 | 158 |
| 2019 | 2 | 164 |
| 2020 | 4 | 134 |
| 2021 | 1 | 223 |
| 2022 | 6 | 180 |
| 2023 | 6 | 193 |
| 2024 | 6 | 181 |
| 2025 | 7 | 214 |
| 2026 | 8 | 177 |
Compare with all 510(k) review times · Search every FGE clearance
Top FGE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cordis Corp. | 37 | 2014-03-12 |
| Boston Scientific Corp | 35 | 2015-11-20 |
| Wilson-Cook Medical, Inc. | 20 | 2017-10-13 |
| Cook, Inc. | 20 | 2013-10-07 |
| Guidant Corp. | 17 | 2004-01-02 |
139 more applicants have FGE clearances. See the full list in Caduvo.
Most recent FGE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254179 | Canyon Medical, Inc. | Drainage Catheter | 2026-09-18 | 269 |
| K262913 | Medtronic, Inc. | Protégé EverFlex Self-expanding Peripheral Stent System | 2026-09-17 | 29 |
| K260835 | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | ARCHIMEDES Biodegradable Stent (Medium) | 2026-07-27 | 136 |
| K253393 | Hangzhou AGS MedTech Co., Ltd. | Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 | 2026-06-24 | 267 |
| K253832 | Mirco-Tech (Nanjing) Co., Ltd. | Dilation Balloon Catheter | 2026-04-24 | 144 |
Recalls for FGE devices
451 product recalls in 95 recall events; 74 initiated in the last five years and 75 still open. Most recent: 2026-08-19.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 43 |
| 2019 | 13 |
| 2020 | 2 |
| 2021 | 28 |
| 2022 | 22 |
| 2023 | 19 |
| 2024 | 8 |
| 2025 | 1 |
| 2026 | 10 |
Frequently asked questions
What is FDA product code FGE?
FGE is the FDA product code for stents, drains and dilators for the biliary ducts. It is a Class II device, regulated under 21 CFR 876.5010 and reviewed by the Gastroenterology and Urology panel.
What device class is FGE?
Class II, regulation 21 CFR 876.5010. Typical premarket route: 510(k).
How long does a 510(k) take for product code FGE?
Across 478 cleared submissions the average was 127 days from receipt to decision (median 84).
Which companies have the most FGE clearances?
Cordis Corp. (37); Boston Scientific Corp (35); Wilson-Cook Medical, Inc. (20); Cook, Inc. (20); Guidant Corp. (17).
Have FGE devices been recalled?
Yes: 451 product recalls across 95 recall events; the most recent began 2026-08-19.
Next steps
- Run an FDA pathway report with predicate devices for product code FGE
- Run a recall and safety report across every FGE manufacturer
- Watch product code FGE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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