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VIDAMED TUNA (Transurethral Needle Ablation) System

by Vidamed, Inc.

510(k) K960918

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960918 Date8 Oct 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VIDAMED TUNA (Transurethral Needle Ablation) System is a transurethral device designed for the ablation of prostate tissue using radiofrequency (RF) energy. It is classified as a transurethral needle ablation system, intended for treating urinary outflow obstruction caused by benign prostatic hyperplasia (BPH).

The system includes the TUNA 3 Catheter, the VIDAMED Model 7205 RF Generator, a Return Electrode, Rectal Monitoring Tape, and TUNA Optics. It is supplied as a reusable device with sterile accessories and is regulated under FDA 510(k) clearance (K960918), classified as substantially equivalent under the General, Plastic Surgery advisory committee. The RF Generator delivers up to 30W (15W per channel) of power for tissue ablation.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the VIDAMED TUNA System primarily used for in clinical practice?

    The VIDAMED TUNA (Transurethral Needle Ablation) System is designed to treat urinary outflow obstruction caused by benign prostatic hyperplasia (BPH). It uses radiofrequency (RF) energy to ablate prostate tissue transurethrally, helping to relieve symptoms associated with BPH.

  • Is the VIDAMED TUNA System reusable, and if so, what components are considered sterile?

    The VIDAMED TUNA System itself is reusable, but it is supplied with sterile accessories. The TUNA 3 Catheter, TUNA Optics, Return Electrode, and Rectal Monitoring Tape are provided as sterile components for single-use during procedures.

  • How much power does the RF Generator in the VIDAMED TUNA System deliver for tissue ablation?

    The VIDAMED Model 7205 RF Generator delivers up to 30 watts of power, with a maximum of 15 watts per channel, to perform the radiofrequency ablation of prostate tissue.

  • What regulatory pathway was followed for FDA clearance of the VIDAMED TUNA System?

    The VIDAMED TUNA System received FDA clearance through a 510(k) submission (K960918) and was classified as substantially equivalent under the General, Plastic Surgery advisory committee. The clearance was granted in 1996, following a traditional review process.