FDA product code · Gastroenterology, Urology · Class 2
FGE: Stents, Drains And Dilators For The Biliary Ducts
FGE is FDA's product code for "Stents, Drains And Dilators For The Biliary Ducts": a Class 2 device classified under 21 CFR 876.5010, reviewed by the Gastroenterology, Urology panel. FDA flags it as an implant and life-sustaining or life-supporting.
510(k) review time for FGE
Across 47 510(k) clearances under FGE decided from 2018-01-01 to 2026-10-06, the median was 188 days from FDA receipt to decision. Half took between 83 and 260 days, and 80% were decided within 262 days. These are past clearances, not a forecast for a new submission.
| Fastest | 18 |
|---|---|
| 25th percentile | 83 |
| Median | 188 |
| 75th percentile | 260 |
| 80th percentile | 262 |
| 90th percentile | 273 |
| Slowest | 426 |
| Year | Median days | n |
|---|---|---|
| 2018 | 215 | 7 |
| 2022 | 101 | 6 |
| 2023 | 199 | 6 |
| 2024 | 188 | 6 |
| 2025 | 257 | 7 |
| 2026 (to 10-06, partial) | 153 | 8 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FGE in the public FDA record
| 510(k) clearances, all years | 476 |
|---|---|
| Device recalls | 450 |
| Establishment listings | 543 |
| GUDID device identifiers | 4,882 |
Counts of records, not of devices or events. Adverse event reports for FGE are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite FGE
No FDA recognized consensus standard cites FGE by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.
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- KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
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