# K082464: Prostiva RF Therapy Hand Piece, Model 8929

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Oct 27, 2008 after 61 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TUNA Therapy Model 8929 Hand Piece (branded as: PROSTIVA® RF Therapy Model 8929 Hand Piece): named in the summary without a submission number

## 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 cm 3.

Source page: https://510kreport.com/device/K082464
Methodology: https://510kreport.com/methodology