510(k) · Cleared
Recalled · Class II · 2025Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venclose, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 9, 2016 as substantially equivalent to K040638 (Vnus Medical Technologies, Inc., 2004) and 1 other predicate after a 175-day review. Its family tree reaches back 9 generations to 1995. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 9, 2016
- Review
- 175 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 9 generations to K943450 (1995). 25 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations between
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK030557 Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2003
- 1 generation backK040638 Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc. · 2004
- This deviceK160754 Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK211806 Venclose digiRF Generator with Maven Catheter, Venclose Maven…Venclose, Inc. · 2021 · Recalled
- Descendant · cites it directly · 1 of its ownK250068 Venclose digiRF Generator (VCRFG1)Venclose, Inc. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK252316 Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter…Venclose, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 3 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 2 generations backK030557 Modification to Vnus Closure SystemVnus Medical Technologies, Inc. · 2003
- 1 generation backK040638 Vnus Radiofrequency Generator, Model RFG2Vnus Medical Technologies, Inc. · 2004
- This deviceK160754 Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)Venclose, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF…Venclose, Inc. · 2021 · cites it directly2descendants
- K250068Venclose digiRF Generator (VCRFG1)Venclose, Inc. · 2025 · cites it directly1descendant
- K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)Venclose, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −8 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −3 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −2 | K030557 | Modification to Vnus Closure System | Vnus Medical Technologies, Inc. | 2003 | — |
| −1 | K040638 | Vnus Radiofrequency Generator, Model RFG2 | Vnus Medical Technologies, Inc. | 2004 | — |
| 0 (this device) | K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) | Venclose, Inc. | 2016 | — |
| +1 | K211806 | Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose… | Venclose, Inc. | 2021 | 1 |
| +1 | K250068 | Venclose digiRF Generator (VCRFG1) | Venclose, Inc. | 2025 | 1 |
| +1 | K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60… | Venclose, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 2 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K040638 | Vnus Radiofrequency Generator, Model RFG2Summary page 4…ts with superficial vein reflux. Predicate Device(s): The Venclose™ Radiofrequency System is substantially equivalent to the following predicate devices. K040638 VNUS RF Generator K061373 VNUS ClosureFast Catheter Venclose, Inc.… | 2004 |
| * | K061373 | Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100Summary page 4…dicate Device(s): The Venclose™ Radiofrequency System is substantially equivalent to the following predicate devices. K040638 VNUS RF Generator K061373 VNUS ClosureFast Catheter Venclose, Inc. Page 1 of 4… | 2006 |
| † | K111887 | Closurefast Radiofrequency Catheter | 2011 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2025 | Class II | Z-2638-2025 | Software Design Change | Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated… |
| Sep 4, 2024 | Class II | Z-0371-2025 | Employee error | The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K211806 (Venclose, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K040638.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Venclose™ Radiofrequency System (Generator and Catheters) is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.
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/K160754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160754: Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160754
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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