510(k) · Cleared
Recalled · Class II · 2026StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation - · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Dec 12, 2023 as substantially equivalent to K221515 (Boston Scientific Corporation, 2023) after a 28-day review. Its family tree reaches back 9 generations to 1993. 1 of the 30 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 12, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- FGB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931154 (1993). 26 ancestors in all, the oldest K843084 (1985). 3 later devices descend from it, 2 citing it directly. 1 of the 30 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations between
- 3 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 2 generations backK153049 LithoVue SystemBoston Scientific Corporation · 2015
- 1 generation backK221515 StoneSmart Connect Console, LithoVue Elite Single Use Digital…Boston Scientific Corporation · 2023
- This deviceK233645 StoneSmart Connect Console, LithoVue Elite Standard Deflection…Boston Scientific Corporation - · 2023
- Descendant · cites it directly · 1 of its ownK241598 LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard…Boston Scientific Corporation · 2024
- Descendant · cites it directly · 0 of its ownK261153 LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK252703 LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard…Boston Scientific Corporation · 2025
Show all 9 generations
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 7 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 6 generations backK021074 Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc. · 2002
- 5 generations backK030960 Ecn Electronic Video CystonephroscopeAcmi Corporation · 2003
- 4 generations backK042225 Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation · 2004
- 3 generations backK060269 Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation · 2006
- 2 generations backK153049 LithoVue SystemBoston Scientific Corporation · 2015
- 1 generation backK221515 StoneSmart Connect Console, LithoVue Elite Single Use Digital…Boston Scientific Corporation · 2023
- This deviceK233645 StoneSmart Connect Console, LithoVue Elite Standard Deflection…Boston Scientific Corporation - · 2023
Class I recalls in this family
- K912120 Urf-P2 Ureterorenofiberscope/Choledochofiberscope7 generations back · 1991
Most influential descendants
Showing 3 of 3 · See all- K241598LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure…Boston Scientific Corporation · 2024 · cites it directly1descendant
- K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation · 2026 · cites it directly0descendants
- K252703LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure…Boston Scientific Corporation · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −8 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −7 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −6 | K021074 | Visera Cystovideoscope Olympus Cyf Type V/VA | Olympus America, Inc. | 2002 | — |
| −5 | K030960 | Ecn Electronic Video Cystonephroscope | Acmi Corporation | 2003 | — |
| −4 | K042225 | Acmi Invisio Icn, Models Icn-0564 and Icn-0565 | Acmi Corporation | 2004 | — |
| −3 | K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope System | Acmi Corporation | 2006 | — |
| −2 | K153049 | LithoVue System | Boston Scientific Corporation | 2015 | — |
| −1 | K221515 | StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible… | Boston Scientific Corporation | 2023 | — |
| 0 (this device) | K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite… | Boston Scientific Corporation - | 2023 | — |
| +1 | K241598 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with… | Boston Scientific Corporation | 2024 | — |
| +1 | K261153 | LithoVue Elite Digital Flexible Ureteroscope System | Boston Scientific Corporation | 2026 | — |
| +2 | K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with… | Boston Scientific Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1991 | 2 | 1 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
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 FGB device
- #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 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 |
|---|---|---|---|
| * | K221515 | StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope…Summary page 6…FGB 510(k) Submitter/Holder: Boston Scientific Corporation, Marlborough, MA 510(k) #/ K221515 Clearance Date February 2, 2023 E. Device Description The LithoVue Elite Digital Fl… | 2023 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 22, 2026 | Class II | Z-3188-2026 | Nonconforming Material/Component | A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation. |
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 · 7 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 26 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241598 (Boston Scientific Corporation, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K221515.
How does its category compare?
All FGB devicesFGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FGB
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGB
134in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGB
15in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGB
1,307in 2025
MAUDE reports naming product code FGB, 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 | 6 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 142 |
| 2018 | 4 | 191 | 0 | 118 |
| 2019 | 2 | — | 0 | 207 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 3 | 191 | 0 | 325 |
| 2022 | 5 | 205 | 4 | 455 |
| 2023 | 8 | 183 | 1 | 458 |
| 2024 | 16 | 217 | 15 | 572 |
| 2025 | 17 | 134 | 0 | 1,307 |
| 2026 | 9 | 140 | 1 | — |
What is it indicated for?
The LithoVue Elite Digital Flexible Ureteroscope System is intended to by used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233645 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233645: StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233645
Report an extraction error
Are you the manufacturer?
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