FDA product code · Gastroenterology, Urology
FGEStents, Drains And Dilators For The Biliary Ducts
Product code FGE covers Stents, Drains And Dilators For The Biliary Ducts, a Class II device regulated under 21 CFR 876.5010. FDA has cleared 475 devices in this code, 9 of them in the last 12 months. Median review time across the 475 most recent decisions is 84 days. openFDA lists 448 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 876.5010
- Review panel
- Gastroenterology, Urology
- Clearances
- 475
What is happening in FGE right now?
FGE (Stents, Drains And Dilators For The Biliary Ducts) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2626-2026, Z-2627-2026, Z-2628-2026, Z-2629-2026, Z-2630-2026). 5 first-time filers in the last 12 months, including Hangzhou AGS MedTech Co., Ltd. and Mirco-Tech (Nanjing) Co., Ltd (K253393, K253832, K253987, K253132, K251229). The code is crowded, scoring 90 of 100 — 131 companies hold a clearance here and 9 arrived in the last 12 months (FGE:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2626-2026, Z-2627-2026, Z-2628-2026, Z-2629-2026, Z-2630-2026 |
| New entrant | Worth knowing | K253393, K253832, K253987, K253132, K251229 |
| Crowding | Context | FGE:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in FGE?
FDA has cleared 475 devices under product code FGE since the 510(k) programme began in 1976, 9 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253393 | 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 | Hangzhou AGS MedTech Co., Ltd. | |
| K253832 | Dilation Balloon Catheter | Mirco-Tech (Nanjing) Co., Ltd. | |
| K251658 | Endoflux Biliary & Pancreatic Stent Sets | Medi-Globe GmbH | |
| K253987 | BARE Wireguided Balloon Dilation Catheter (1235) | GIE Medical | |
| K253132 | Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. | |
| K251123 | Niti-S Biliary Stent; Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | |
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | Bioteque Corporation | |
| K250409 | Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) | Olympus Medical Systems Corporation | |
| K251229 | EndoFixTissue Fixation System | Softac Medical Technologies | |
| K243412 | ARCHIMEDES Biodegradable Pancreatic Stent | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) |
How long does FDA review take for FGE?
The median FDA review time for FGE is 84 days, measured across the 475 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in FGE?
openFDA lists 448 recall records against product code FGE. A recall record covers one firm's corrective action and may span many device lots.
Z-2626-2026Open, ClassifiedBoston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Z-2627-2026Open, ClassifiedBoston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Z-2628-2026Open, ClassifiedBoston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Z-2629-2026Open, ClassifiedBoston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Z-2630-2026Open, ClassifiedBoston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Showing the 5 most recently initiated of 448. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for FGE?
MAUDE holds 5,521 adverse-event reports naming product code FGE, 1,265 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in FGE unusual?
Every month with enough history behind it falls inside FGE's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 126 | Insufficient history | No expected range — too little history | |
| 116 | Insufficient history | No expected range — too little history | |
| 122 | Insufficient history | No expected range — too little history | |
| 109 | Insufficient history | No expected range — too little history | |
| 160 | Insufficient history | No expected range — too little history | |
| 160 | Insufficient history | No expected range — too little history | |
| 101 | Insufficient history | No expected range — too little history | |
| 159 | Insufficient history | No expected range — too little history | |
| 131 | Insufficient history | No expected range — too little history | |
| 118 | Insufficient history | No expected range — too little history | |
| 116 | Insufficient history | No expected range — too little history | |
| 143 | Insufficient history | No expected range — too little history | |
| 163 | Insufficient history | No expected range — too little history | |
| 164 | Insufficient history | No expected range — too little history | |
| 167 | Insufficient history | No expected range — too little history | |
| 200 | Insufficient history | No expected range — too little history | |
| 163 | Insufficient history | No expected range — too little history | |
| 158 | Insufficient history | No expected range — too little history | |
| 161 | Insufficient history | No expected range — too little history | |
| 180 | Insufficient history | No expected range — too little history | |
| 214 | Insufficient history | No expected range — too little history | |
| 113 | 117–213 | Below expected (117–213) | |
| 124 | 88–172 | Within expected (88–172) | |
| 157 | 103–185 | Within expected (103–185) | |
| 160 | 111–195 | Within expected (111–195) | |
| 160 | 106–185 | Within expected (106–185) | |
| 157 | 114–197 | Within expected (114–197) | |
| 152 | 183–308 | Below expected (183–308) | |
| 182 | 106–222 | Within expected (106–222) | |
| 162 | 117–239 | Within expected (117–239) | |
| 168 | 110–234 | Within expected (110–234) | |
| 149 | 98–210 | Within expected (98–210) | |
| 190 | 108–231 | Within expected (108–231) | |
| 159 | 142–261 | Within expected (142–261) | |
| 124 | 110–210 | Within expected (110–210) | |
| 182 | 101–226 | Within expected (101–226) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in FGE.
Who has entered FGE in the last year?
5 companies filed in FGE for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Hangzhou AGS MedTech Co., Ltd. | K253393 | |
| Mirco-Tech (Nanjing) Co., Ltd. | K253832 | |
| GIE Medical | K253987 | |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | K253132 | |
| Softac Medical Technologies | K251229 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in FGE?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in FGE?
Across the 475 most recent decisions, these applicants filed most often in FGE.
| Applicant | Recent clearances |
|---|---|
| Cordis Corp. | 37 |
| Boston Scientific Corp | 35 |
| Cook, Inc. | 20 |
| Wilson-Cook Medical, Inc. | 20 |
| Guidant Corp. | 17 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
4 companies in FGE file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Boston Scientific Corporation | 56 | 3 |
| Cordis Corporation | 38 | 2 |
| Cook Incorporated | 22 | 2 |
| Guidant Corporation | 20 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch FGE
Get an email the morning anything changes in FGE — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.