# K012587: RF Generators, Disposable Cartridge Kit, Disposable Cartridge, Reusable Handle, Disoisable Handpiece Reusable Telescope

- Pathway: 510(k) (Traditional)
- Applicant: Vidamed, Inc.
- Decided: Dec 11, 2001 after 123 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 no predicate by number.

## Indications for use
The TUNA® System Product Family, including Precision™ TUNA® Office System and PROVU™ 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/K012587
Methodology: https://510kreport.com/methodology