# K021804: Precision Plus Tuna Office System; Presision Tuna Office System; Provu Tuna System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Aug 28, 2002 after 86 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: 3 generations back to K951245 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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 2.
- K002583: Tuna (Trans Urethra Needle) Office System, Vidamed, Inc. (2001) Summary page 2.
- K965061: Vidamed Modedl 7600 RF Generator, Vidamed, Inc. (1997) Summary page 1.

## Indications for use
The TUNA System Product Family, including Precision Plus TUNA Office System, 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/K021804
Methodology: https://510kreport.com/methodology