510(k) · Decided
DecidedAdvance Biliary Balloon Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Cleared on Jun 22, 2018 as substantially equivalent to K011018 (Taut, Inc., 2001) after a 233-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Jun 22, 2018
- Review
- 233 days
- Class
- Class II
- Product code
- GCA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011018 (2001). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K212582SpyGlass Discover Balloon Dilation CatheterBoston Scientific Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011018 | Taut Balloon Catheter, Model 50640 | Taut, Inc. | 2001 | — |
| 0 (this device) | K173414 | Advance Biliary Balloon Catheter | Cook Incorporated | 2018 | — |
| +1 | K212582 | SpyGlass Discover Balloon Dilation Catheter | Boston Scientific Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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 GCA? 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 GCA device
- #1 K253013 Disposable Stone Retrieval Balloon Catheterscore 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K011018 | Taut Balloon Catheter, Model 50640Summary page 4…(DRGUD) Gastroenterology Devices Branch (GEDB) Predicate Devices: The predicate device is the Taut Biliary Balloon Catheter (K011018) from Taut, Inc. Reference Devices: To support the use of an 8-mm balloon catheter in the biliary tree: - Olympus Single Use Ba… | 2001 |
| † | K050502 | Single Use Balloon Dilator Maxpasstm | 2005 |
| † | K130484 | Maxforce Biliary Dilatation Catheter and Hurricane RX Biliary Catheter | 2013 |
| † | K033875 | Atb All-Terrain Balloon Pta Dilatation Catheter | 2004 |
| † | K091527 | Advance 35LP Low Profile Pta Balloon Dilatation Catheter | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212582 | SpyGlass Discover Balloon Dilation Catheter | 2022 | 0 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K212582 (Boston Scientific Corporation, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GCA devicesGCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GCA
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GCA
Too few GCA 510(k)s in any year since 2007 to give a median.
Recalls per year · GCA
No recall names GCA since 2007.
Adverse event reports per year · GCA
24in 2025
MAUDE reports naming product code GCA, 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 | 1 | — | 0 | 6 |
| 2008 | 0 | — | 0 | 36 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 1 | — | 0 | 85 |
| 2018 | 2 | — | 0 | 38 |
| 2019 | 1 | — | 0 | 38 |
| 2020 | 2 | — | 0 | 20 |
| 2021 | 1 | — | 0 | 8 |
| 2022 | 1 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 24 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Advance Biliary Balloon Catheter is indicated for laparoscopic and general surgical procedures for the dilation of the cystic duct to facilitate common bile duct exploration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173414: Advance Biliary Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173414
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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