510(k) · Cleared
ClearedFlexima
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Oct 16, 1998 after an 88-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 16, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Microvasive® Biliary Stent System Named without a submission number | |
| * | — | Medi-Tech® Flexima™ Biliary Drainage Catheter Named without a submission number | |
| * | — | Wilson-Cook® Nasal Biliary Drainage Set Named without a submission number |
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?
The Flexima™ Nasobiliary Catheter is indicated for prolonged access to the biliary ductal system via the nose, including: Decompression of an obstructed bile duct in acute suppurative cholangitis. Temporary or short-term decompression of the common bile duct, similar to that which follows unsuccessful stone extraction after endoscopic sphincterotomy. Prevention of stone impaction after endoscopic sphincterotomy. Infusion of contrast medium for repeat…
Read the full statement (180 words)
The Flexima™ Nasobiliary Catheter is indicated for prolonged access to the biliary ductal system via the nose, including:
Decompression of an obstructed bile duct in acute suppurative cholangitis.
Temporary or short-term decompression of the common bile duct, similar to that which follows unsuccessful stone extraction after endoscopic sphincterotomy.
Prevention of stone impaction after endoscopic sphincterotomy.
Infusion of contrast medium for repeat cholangiography.
Instillation of various therapeutic solutions, including antibiotics (for acute bacterial cholangitis) or saline (to flush sludge or small stones after endoscopic sphincterotomy).
Preoperative biliary decompression to decrease jaundice (thereby decreasing perioperative complications) in patients undergoing elective biliary tract surgery.
Temporary biliary decompression in patients who are septic or who have severe coagulopathy. Once infection has been controlled or coagulopathy corrected, sphincterotomy can be performed, and a large stent can be inserted for long-term therapy.
Access for intraluminal irradiation therapy, using iridium.
Aspiration of bile for chemical and bacteriologic studies (e.g., to identify causative agents in bacterial cholangitis or to determine thie lithogenicity of bile in patients with cholestasis).
Facilitating the healing process in traumatic or surgical biliary fistulae.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982508: Flexima.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982508
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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