# K101139: Prostiva RF Therapy Model 8929 Hand Piece

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: May 21, 2010 after 29 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 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) Prostiva RF Therapy Model 8929 Hand Piece: named in the summary without a submission number

## Most influential descendants
- 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
- K180237: Rezum System (2018), 4 descendants of its own

## Indications for use
The Prostiva RF 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/K101139
Methodology: https://510kreport.com/methodology