# K965061: Vidamed Modedl 7600 RF Generator

- Pathway: 510(k) (Traditional)
- Applicant: Vidamed, Inc.
- Decided: Jan 28, 1997 after 41 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). 4 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 17 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.
- K963180: Vidamed RF Generator Data Recorder, Vidamed, Inc. (1996) Summary page 1.

## Most influential descendants
- 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
- K160417: Rezum System (2016), 5 descendants of its own

## Indications for use
The VIDAMED Model 7600 RF Generator is indicated for use as part of the VIDAMED TUNA System to deliver RF energy and record patient treatment data. 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/K965061
Methodology: https://510kreport.com/methodology