# K014224: Precision Plus Tuna Office System

- Pathway: 510(k) (Special)
- Applicant: Vidamed, Inc.
- Decided: Jan 23, 2002 after 28 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
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices 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) Precision™ TUNA® Office System: named in the summary without a submission number
- (no number) PROVu™ TUNA® System: named in the summary without a submission number

## 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

## Indications for use
The Precision™ Plus TUNA® Office 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/K014224
Methodology: https://510kreport.com/methodology