# K113380: Prostiva RF Therapy Hand Piece Prostiva RF Therapy RF Generator

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Nov 15, 2012 after 365 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K951245 (1995). 9 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101139: Prostiva RF Therapy Model 8929 Hand Piece, Medtronic, Inc. (2010) Summary page 1.
- K052413: Tuna System, Models 8909, 8929, 8930, 8934, Medtronic Vascular (2005) Summary page 1.
- K002583: Tuna (Trans Urethra Needle) Office System, Vidamed, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K190093: Rezum Delivery Device, Rezum Generator (2019), 3 descendants of its own

## Recalls of this device
- Oct 21, 2013 · Class II · Z-0182-2014: A Hand Piece high deployment force exceeded the maximum specification.
- Feb 27, 2013 · Class II · Z-1031-2013: Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the foots

## Indications for use
The Prostiva, REF Therapy 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.

Source page: https://510kreport.com/device/K113380
Methodology: https://510kreport.com/methodology