# K960918: Vidamed Tuna (Transurethral Needle Ablation) System

- Pathway: 510(k) (Traditional)
- Applicant: Vidamed, Inc.
- Decided: Oct 8, 1996 after 216 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: 1 generation back to K951245 (1995). 2 ancestors in all.
19 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951245: Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical Cartridge) Accessory, Vidamed, Inc. (1995) Summary page 1.
- K955035: Vidamed Series 7205 Electrosurgical Generator, Vidamed, Inc. (1995) Summary page 1.
- (no number) Radionics device (pre-amendments): named in the summary without a submission number

## Most influential descendants
- K965061: Vidamed Modedl 7600 RF Generator (1997), 12 descendants of its own
- K052413: Tuna System, Models 8909, 8929, 8930, 8934 (2005), 10 descendants of its own
- K113380: Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator (2012), 9 descendants of its own
- K142248: Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope (2015), 8 descendants of its own
- K150786: Rezum System (2015), 7 descendants of its own

## Indications for use
The 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/K960918
Methodology: https://510kreport.com/methodology