Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope— 510(k) K142248

Name: FDA 510(k) clearance K142248
Creator: U.S. Food and Drug Administration
Published: 2015-02-20

Substantially Equivalent

Urologix, Inc.

FDA 510(k) clearance K142248 for Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope, Substantially Equivalent on 2015-02-20. Applicant: Urologix, Inc.. Device class: 2.

Clearance details

Applicant: Urologix, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2014-08-14
Decision date: 2015-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEI

view all

K254185 — Potenza Prime2026-09-11
K262364 — Ellian Enigma RF Device2026-09-02
K253859 — Scarlet Pro (Scarlet Pro)2026-08-27
K252535 — Inno-Switch Laparoscopic Instruments2026-08-25
K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.