510(k) · Cleared
ClearedErcp Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Cleared on Mar 28, 1997 after a 234-day review. The FDA summary names no predicate by number.
- Decided
- Mar 28, 1997
- Review
- 234 days
- Class
- Class II
- Product code
- ODD
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by 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 ODD? 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 ODD device
- #1 K250573 Single Use Cannula V…score 9.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by 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 ODD devicesODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ODD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODD
Too few ODD 510(k)s in any year since 2007 to give a median.
Recalls per year · ODD
No recall names ODD since 2007.
Adverse event reports per year · ODD
4in 2025
MAUDE reports naming product code ODD, 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 | 1 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 0 | — | 0 | 26 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ERCP is a diagnostic procedure for suspected biliary tract obstruction such as strictures or stones. The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage.
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/K963051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963051: Ercp Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963051
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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