Product code FGE: 510(k) clearances and predicates
Product code FGE covers Drainage Catheter. FDA lists 478 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
478 clearances on file under product code FGE. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 6 |
| 2023 | 6 |
| 2024 | 6 |
| 2025 | 7 |
| 2026 so far | 8 |
Recent clearances
Newest FGE clearances in the FDA index, with applicant and decision date:
- K254179, Drainage Catheter, applicant Canyon Medical, Inc., decided 2026-09-18. FDA record
- K262913, Protégé EverFlex Self-expanding Peripheral Stent System, applicant Medtronic, Inc., decided 2026-09-17. FDA record
- K260835, ARCHIMEDES Biodegradable Stent (Medium), applicant Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.), decided 2026-07-27. FDA record
- 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, applicant Hangzhou AGS MedTech Co., Ltd., decided 2026-06-24. FDA record
- K253832, Dilation Balloon Catheter, applicant Mirco-Tech (Nanjing) Co., Ltd., decided 2026-04-24. FDA record
- K251658, Endoflux Biliary & Pancreatic Stent Sets, applicant Medi-Globe GmbH, decided 2026-04-16. FDA record
- K253987, BARE Wireguided Balloon Dilation Catheter (1235), applicant GIE Medical, decided 2026-03-13. FDA record
- K253132, Single use stone retrieval balloons, applicant Zhejiang Chuangxiang Medical Technology Co., Ltd., decided 2026-03-06. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Protégé EverFlex Self-expanding Peripheral Stent System, ARCHIMEDES Biodegradable Stent (Medium). Watch new FGE clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code FGE?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent FGE clearances include Drainage Catheter.
How many 510(k) clearances use product code FGE?
478 at the time this page was generated, from openFDA records.
How do I find a predicate device under FGE?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new FGE clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.