510(k) · Cleared
ClearedEndoCure Model EUR078A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endocure Technologies, Inc. · FBN Choledochoscope And Accessories, Flexible/Rigid
Cleared on Jun 7, 2016 as substantially equivalent to K912120 (Olympus Corp., 1991) after a 46-day review. Its family tree reaches back 1 generation to 1991. 1 of the 2 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 7, 2016
- Review
- 46 days
- Class
- Class II
- Product code
- FBN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912120 (1991). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK912120 Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · Recalled (Class I)
- This deviceK161147 EndoCure Model EUR078AEndocure Technologies, Inc. · 2016
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscopedirect predicate · 1991
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912120 | Urf-P2 Ureterorenofiberscope/Choledochofiberscope | Olympus Corp. | 1991 | Class I |
| 0 (this device) | K161147 | EndoCure Model EUR078A | Endocure Technologies, Inc. | 2016 | — |
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.
1 device in this family has a Class I recall. 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 FBN device
- #1 K254153 Single-use Video Scope; PB Digital Controllerscore 14.4 · 12 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 |
|---|---|---|---|
| * | K912120 | Urf-P2 Ureterorenofiberscope/CholedochofiberscopeSummary page 4…Company Product 510(k) Number Olympus, Inc. Ureterorenofiberscope/Choledochofiberscope K912120 DEVICE DESCRIPTION 807.92(a)(4) EndoCure Model EUR078A is used during the exam… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall, Class I.
- 3 other devices also cite its predicate K912120.
How does its category compare?
All FBN devicesFBN Choledochoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · FBN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBN
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FBN
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FBN
118in 2025
MAUDE reports naming product code FBN, 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 | 0 | — | 0 | 1 |
| 2008 | 3 | 64 | 0 | 5 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 168 |
| 2017 | 0 | — | 0 | 224 |
| 2018 | 1 | — | 0 | 639 |
| 2019 | 1 | — | 0 | 105 |
| 2020 | 1 | — | 1 | 173 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 0 | — | 0 | 283 |
| 2023 | 4 | 215 | 1 | 105 |
| 2024 | 2 | — | 1 (1) | 107 |
| 2025 | 3 | 150 | 0 | 118 |
| 2026 | 3 | 175 | 1 | — |
What is it indicated for?
The EndoCure Model EUR078A has been designed for endoscopic observation and diagnosis within both the urinary tract (ureter, renal pelvis, and renal calyx) and biliary tract (common bile duct and hepatic duct). Therapeutic endoscopic procedures using various kinds of accessories are also possible, and include the ability to extract or fragment stones within these organs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161147: EndoCure Model EUR078A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161147
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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