510(k) · Cleared
ClearedAll Slicone Drainage, Penrose Drain, CWV Drain, Thoracic Drain Tubes and CWV Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fortune Medical Instrument Corp. · GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Cleared on May 27, 1998 after a 77-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 27, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- GCA
- 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 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?
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 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.
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?
To preserve patency of the common duct and to ensure drainage of bile out of the body until edema in the common duct has subsided enough for bile to drain into the duodenum normally. The T-Y Drainage Tube is also allowed for flush in the common duct.
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/K980917 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980917: All Slicone Drainage, Penrose Drain, CWV Drain, Thoracic Drain Tubes and CWV Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980917
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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