Identifiers
- 510(k) Number
- K142248 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Prostiva RF Therapy System is a minimally invasive device designed to treat lower urinary tract symptoms caused by benign prostatic hyperplasia. The system utilizes radio frequency energy to ablate prostate tissue and features a generator with touch screen controls that monitors urethral and prostatic temperatures.
This system consists of a generator, hand piece, return electrode, tubing system, and telescope, and is operated by a clinician in a clinical setting. It has received FDA 510k clearance. The generator includes computerized graphics to allow the physician to view the treatment process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Prostiva® RF Product Components - urologix.com, Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva ..., Prostiva® RF Therapy Manuals and Forms - Urologix
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142248 | Class II | Active |
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Manufacturer
- Manufacturer
- Urologix, Inc.
Sources (1)
- FDA 510(k) K142248 24 fields · synced Sep 22, 2026