510(k) · Cleared
ClearedTuna 5 Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vidamed, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Apr 30, 1997 as substantially equivalent to K960918 (Vidamed, Inc., 1996) and 1 other predicate after a 125-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Apr 30, 1997
- Review
- 125 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951245 (1995). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK951245 Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable…Vidamed, Inc. · 1995
- 1 generation backK960918 Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc. · 1996
- This deviceK965199 Tuna 5 CatheterVidamed, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK011190 Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK020126 Modification to Surx Radiofrequency Electrosurgical Generator System…Surx, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK020952 Surx RF SystemSurx, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK042132 Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · Recalled
- Descendant · cites it directly · 0 of its ownK991847 Thermoflex SystemArgomed, Inc. · 1999
Most influential descendants
Showing 5 of 5 · See all- K011190Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System)Surx, Inc. · 2002 · cites it directly3descendants
- K020126Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories…Surx, Inc. · 2002 · 2 generations on2descendants
- K020952Surx RF SystemSurx, Inc. · 2002 · 2 generations on1descendant
- K042132Novasys Transurethral RF SystemNovasys Medical, Inc. · 2004 · 3 generations on0descendants
- K991847Thermoflex SystemArgomed, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951245 | Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical… | Vidamed, Inc. | 1995 | — |
| −1 | K960918 | Vidamed Tuna (Transurethral Needle Ablation) System | Vidamed, Inc. | 1996 | — |
| 0 (this device) | K965199 | Tuna 5 Catheter | Vidamed, Inc. | 1997 | — |
| +1 | K011190 | Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP… | Surx, Inc. | 2002 | — |
| +2 | K020126 | Modification to Surx Radiofrequency Electrosurgical Generator System and… | Surx, Inc. | 2002 | — |
| +2 | K020952 | Surx RF System | Surx, Inc. | 2002 | — |
| +3 | K042132 | Novasys Transurethral RF System | Novasys Medical, Inc. | 2004 | 1 |
| +1 | K991847 | Thermoflex System | Argomed, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 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 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 |
|---|---|---|---|
| * | K960918 | Vidamed Tuna (Transurethral Needle Ablation) SystemSummary page 1…reatment of BPH. The TUNA 5 Catheter is substantially equivalent to two previously cleared VIDAMED accessory electrodes, the TUNA 3 Catheter which was cleared in 510(k) K960918, and the VIDAMED AEC which was cleared in 510(k) K951245. Standards/Classifications The VIDAMED TUNA System is a regulatory Cla… | 1996 |
| * | K951245 | Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical Cartridge)…Summary page 1…ivalent to two previously cleared VIDAMED accessory electrodes, the TUNA 3 Catheter which was cleared in 510(k) K960918, and the VIDAMED AEC which was cleared in 510(k) K951245. Standards/Classifications The VIDAMED TUNA System is a regulatory Class II medical device. | 1995 |
What descends from it? (5)
2 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)
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 2 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K011190 (Surx, Inc., 2002) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K960918.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 TUNA 5 Catheter is indicated for use as part of the VIDAMED TUNA System. The VIDAMED TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.
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/K965199 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965199: Tuna 5 Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965199
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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