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Microsurgeon Microwave Tissue Ablation Device, Model MTAD-200

by Microsurgeon, Inc.

510(k) K082565

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 NumberK082565 Date12 Feb 2009ClearedStatusActive

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  • Withdrawn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
NEY
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Microsurgeon Microwave Tissue Ablation Device, Model MTAD-200 is a system for ablation of soft tissue by induction of thermal necrosis in targeted tissue through direct application of microwave energy. It is used with a sterile hand-held disposable patient probe (DPP) to ablate tissue, with lesion sizes determined by the system.

The device is supplied as a reusable system with a disposable patient probe for single-use application. It received FDA 510(k) clearance (K082565) on February 12, 2009, and is classified as a Class II device under regulation number 878.4400 for use in general and plastic surgery settings.

Other devices from Microsurgeon, Inc.

Questions

AI-generated answers, 22 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 Microsurgeon Microwave Tissue Ablation Device, Model MTAD-200 used for?

    The device is used for ablation of soft tissue by inducing thermal necrosis through direct application of microwave energy, targeting specific tissue areas with lesion size determined by system settings during general and plastic surgery procedures.

  • How is the Microsurgeon Microwave Tissue Ablation Device, Model MTAD-200 supplied and is it reusable?

    The device is supplied as a reusable system that includes a sterile, hand-held disposable patient probe (DPP) designed for single-use application; the main unit can be reused after proper cleaning, while the probe is discarded after each patient procedure.

  • What regulatory clearance does the Microsurgeon Microwave Tissue Ablation Device, Model MTAD-200 have?

    The device received FDA 510(k) clearance under submission number K082565 on February 12, 2009, and is classified as a Class II medical device under regulation 878.4400 for use in general and plastic surgery settings.