# K965199: Tuna 5 Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vidamed, Inc.
- Decided: Apr 30, 1997 after 125 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951245 (1995). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960918: Vidamed Tuna (Transurethral Needle Ablation) System, Vidamed, Inc. (1996) Summary page 1.
- K951245: Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical Cartridge) Accessory, Vidamed, Inc. (1995) Summary page 1.

## Most influential descendants
- K011190: Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx LP System) (2002), 3 descendants of its own
- K020126: Modification to Surx Radiofrequency Electrosurgical Generator System and Accessories (Surx TV System) (2002), 2 descendants of its own
- K020952: Surx RF System (2002), 1 descendant of its own
- K042132: Novasys Transurethral RF System (2004), 0 descendants of its own
- K991847: Thermoflex System (1999), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K965199
Methodology: https://510kreport.com/methodology