510(k) · Cleared
ClearedSilicone Biliary Stent/Biliary Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialty Surgical Products, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Sep 19, 1997 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 19, 1997
- Review
- 30 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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.
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?
Percutaneous biliary drainage with the Biliary Stent is utilized for the management of both benign and malignant biliary obstruction. The stent is used to prevent or relieve sepsis, to relieve symptoms of obstruction such as pruritis, and to maintain a pathway for bile flow into the bowel for digestive function. The stent is indicated for malignant biliary obstruction, such as primary bile duct or biliary tract carcinoma, pancreatic carcinoma, metastases…
Read the full statement (108 words)
Percutaneous biliary drainage with the Biliary Stent is utilized for the management of both benign and malignant biliary obstruction. The stent is used to prevent or relieve sepsis, to relieve symptoms of obstruction such as pruritis, and to maintain a pathway for bile flow into the bowel for digestive function.
The stent is indicated for malignant biliary obstruction, such as primary bile duct or biliary tract carcinoma, pancreatic carcinoma, metastases to the porta hepatis, and other malignant conditions causing obstructive jaundice.
The stent can also be used in cases of benign biliary obstruction such as strictures secondary to primary or iatrogenic trauma pancreatitis, biliary calculi, or biliary leaks.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973114: Silicone Biliary Stent/Biliary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973114
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026