510(k) · Cleared
Recalled · 2010Direct Peroral Cholangioscopy Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Jul 19, 2010 as substantially equivalent to K063677 (Wilson-Cook Medical, Inc., 2007) after a 90-day review. Its family tree reaches back 3 generations to 1995. It has been recalled 2 times.
- Decided
- Jul 19, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953951 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK953951 Wilson-Cook Triple Lumen Balloon Stone ExtractorWilson-Cook Medical, Inc. · 1995 · Recalled
- 2 generations backK040129 Tri-EX Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc. · 2004
- 1 generation backK063677 Fusion Quattro Extraction Balloon XLWilson-Cook Medical, Inc. · 2007
- This deviceK101095 Direct Peroral Cholangioscopy BalloonWilson-Cook Medical, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953951 | Wilson-Cook Triple Lumen Balloon Stone Extractor | Wilson-Cook Medical, Inc. | 1995 | 1 |
| −2 | K040129 | Tri-EX Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | 2004 | — |
| −1 | K063677 | Fusion Quattro Extraction Balloon XL | Wilson-Cook Medical, Inc. | 2007 | — |
| 0 (this device) | K101095 | Direct Peroral Cholangioscopy Balloon | Wilson-Cook Medical, Inc. | 2010 | — |
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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K090117 | FDA’s K090117 is Autosafe-Reflex Safety Huber Infusion Set, Autosafe Advantage Safety Huber… Our reading of the summary gave K090117, FDA’s number for Autosafe-Reflex Safety Huber Infusion Set, Autosafe… (Autosafe-Reflex, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “SpyScope Access and Delivery Catheter”. Kept off the family tree. Summary page 1…theter, biliary, surgical (21. CFR 876.501 0, Product Code GCA) Legally Marketed SpyScope Access and Delivery Catheter (K0901 170) Devices: Fusion Quattro Extraction Balloon XL (K063677) Description of the The D… | 2009 |
| * | K063677 | Fusion Quattro Extraction Balloon XLSummary page 1…GCA) Legally Marketed SpyScope Access and Delivery Catheter (K0901 170) Devices: Fusion Quattro Extraction Balloon XL (K063677) Description of the The Direct Peroral Cholangioscopy Balloon is a sterile, single Device:… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 23, 2010 | Not classified | Z-0925-2011 | Other | Product defect; There is a risk of gastrointestinal perforation due to balloon deflation difficulty or air embolism resulting in poor patient outcomes including death. |
| Dec 23, 2010 | Not classified | Z-0926-2011 | Other | There is a risk of gastrointestinal perforation or air embolism due to balloon deflation difficulty, resulting in poor patient outcomes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K063677.
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. 2010, this device’s year, is highlighted.
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?
This device is intended to guide both optical and accessory devices for diagnostic and
therapeutic applications during endoscopic procedures in the pancreaticobiliary system
including the hepatic ducts. Also, used for endoscopic removal of biliary stones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101095: Direct Peroral Cholangioscopy Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101095
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026