510(k) · Cleared
ClearedVeloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corinth Medtech, Inc. · FJL Resectoscope
Cleared on Jun 13, 2019 as substantially equivalent to K190099 (Corinth Medtech, Inc., 2019) and 3 other predicates after a 24-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Jun 13, 2019
- Review
- 24 days
- Class
- Class II
- Product code
- FJL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K951972 (1995). 15 ancestors in all, the oldest K890328 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK951972 Cabot Medical Ultra Flow Cystourethroscope System with Operating &…Cabot Medical Corp. · 1995
- 3 generations backK021166 Acmi Bipolar Rectoscope, Model Eiwe-BRAcmi-Circon Corporation · 2002
- 2 generations backK031001 Acmi Vista CTR Bipolar Loop ElectrodeAcmi Corporation · 2003
- 1 generation backK062720 S-Line Bipolar Resectoscopes and Bipolar ElectrodesRichard Wolf Medical Instruments Corp. · 2007 · Recalled
- This deviceK191341 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion…Corinth Medtech, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK250522 Multi4 SystemMulti4 Medical AB · 2025
Most influential descendants
Showing 1 of 1 · See all- K250522Multi4 SystemMulti4 Medical AB · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951972 | Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic… | Cabot Medical Corp. | 1995 | — |
| −3 | K021166 | Acmi Bipolar Rectoscope, Model Eiwe-BR | Acmi-Circon Corporation | 2002 | — |
| −2 | K031001 | Acmi Vista CTR Bipolar Loop Electrode | Acmi Corporation | 2003 | — |
| −1 | K062720 | S-Line Bipolar Resectoscopes and Bipolar Electrodes | Richard Wolf Medical Instruments Corp. | 2007 | 2 |
| 0 (this device) | K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope… | Corinth Medtech, Inc. | 2019 | — |
| +1 | K250522 | Multi4 System | Multi4 Medical AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 FJL? 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 FJL device
- #1 K221893 KARL STORZ Bipolar Resectoscopes with HF Cablescore 7.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion…Summary page 4…Predicate Device Names 510(k)# Clearance Date Primary Predicate Corinth MedTech, Inc. Veloxion System K190099 March 15, 2019 Predicate #1 Richard Wolf Medical Predicate #2… | 2019 |
| * | K062720 | S-Line Bipolar Resectoscopes and Bipolar ElectrodesSummary page 4…rd Wolf Medical Predicate #2 S-Line Bipolar Resectoscope Instruments K062720 March 22, 2007 (predicate system) & ERBE ESU Corporation… | 2007 |
| * | K042523 | Resection Pump, Resectoscope for Chip Aspiration, Endoscope 25/ 3.3 MM, AccessoriesSummary page 4…hard Wolf Medical Predicate #3 Resection Master & ERBE Instruments K042523 March 18, 2005 (predicate system) ESU Corporation Predicate #4… | 2005 |
| * | K162979 | Veloxion SystemSummary page 4…system) ESU Corporation Predicate #4 Corinth MedTech, Inc. Veloxion System K162979 March 24, 2017 (predicate system) Predicate devices have not been the subject of a design related recall. IV. Devi… | 2017 |
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 |
|---|---|---|---|
| K250522 | Multi4 System | 2025 | 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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 6.8 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K250522 (Multi4 Medical AB, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K190099.
How does its category compare?
All FJL devicesFJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FJL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FJL
Too few FJL 510(k)s in any year since 2007 to give a median.
Recalls per year · FJL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FJL
67in 2025
MAUDE reports naming product code FJL, 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 | 11 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 15 |
| 2010 | 1 | — | 0 | 34 |
| 2011 | 0 | — | 0 | 18 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 0 | — | 1 | 24 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 1 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 50 |
| 2019 | 2 | — | 0 | 53 |
| 2020 | 0 | — | 0 | 55 |
| 2021 | 0 | — | 0 | 54 |
| 2022 | 0 | — | 1 | 74 |
| 2023 | 2 | — | 0 | 74 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 67 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191341 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191341: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191341
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