# K052413: Tuna System, Models 8909, 8929, 8930, 8934

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Nov 17, 2005 after 76 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K951245 (1995). 7 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014224: Precision Plus Tuna Office System, Vidamed, Inc. (2002) Summary page 1.
- K002583: Tuna (Trans Urethra Needle) Office System, Vidamed, Inc. (2001) Summary page 1.
- K965061: Vidamed Modedl 7600 RF Generator, Vidamed, Inc. (1997) Summary page 2.
- K960918: Vidamed Tuna (Transurethral Needle Ablation) System, Vidamed, Inc. (1996) Summary page 1.

## Most influential descendants
- 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
- K180237: Rezum System (2018), 4 descendants of its own

## Recalls of this device
- Jun 5, 2008 · Not classified · Z-1060-2009: Reported incidents of needle retraction failure when using the PROSTIVA RF Model 8929 Hand Piece. The Medtronic Prostiva RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Th

## Indications for use
The TUNA System is indicated for use in 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/K052413
Methodology: https://510kreport.com/methodology