# K963180: Vidamed RF Generator Data Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Vidamed, Inc.
- Decided: Oct 10, 1996 after 57 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 K955035 (1995). 1 ancestor in all.
13 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955035: Vidamed Series 7205 Electrosurgical Generator, Vidamed, Inc. (1995) Summary page 1.

## 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 VIDAMED RF Generator Data Recorder is indicated for use in recording patient treatment data when used in conjunction with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator. The data recorder software does not control or effect the output of power from the RF Generator, nor is it intended to be used in the treatment or diagnosis of any disease.

Source page: https://510kreport.com/device/K963180
Methodology: https://510kreport.com/methodology