# K002583: Tuna (Trans Urethra Needle) Office System

- Pathway: 510(k) (Traditional)
- Applicant: Vidamed, Inc.
- Decided: Feb 13, 2001 after 179 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 4 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K002583
Methodology: https://510kreport.com/methodology