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Zomed Model 500 Electrosurgical Generator Model 200 Electrosurgical Probe

by Zomed Intl. 510(k)

Active United States

510(k) K952072

Overview

The Zomed Model 500 Electrosurgical Generator Model 200 Electrosurgical Probe is an electrosurgical device used for cutting and coagulation during surgical procedures. It consists of a generator unit and a probe that delivers electrical energy to achieve tissue effects.

This device is supplied by Zomed Intl. and has FDA 510(k) clearance with number K952072. It is intended for use in general and plastic surgery settings. The device is classified under product code GEI and was cleared as substantially equivalent on October 4, 1995.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952072 Date4 Oct 1995ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

Other devices from Zomed Intl.

Questions

  • What is the Zomed Model 500 Electrosurgical Generator Model 200 Probe used for?

    The Zomed Model 500 Electrosurgical Generator Model 200 Probe is an electrosurgical device used for cutting and coagulation during surgical procedures. It consists of a generator unit and a probe that delivers electrical energy to achieve tissue effects.

  • How is the Zomed Model 500 Electrosurgical Generator Model 200 Probe supplied?

    The device is supplied by Zomed Intl. and includes both the generator unit and the electrosurgical probe. It is intended for use in general and plastic surgery settings.

  • What is the regulatory status of the Zomed Model 500 Electrosurgical Generator Model 200 Probe?

    The device has FDA 510(k) clearance with number K952072. It was classified under product code GEI and cleared as substantially equivalent on October 4, 1995.

  • Is the Zomed Model 500 Electrosurgical Generator Model 200 Probe reusable or single-use?

    The device data does not specify whether the electrosurgical probe is reusable or single-use. This information would need to be confirmed in the product's instructions for use or by contacting the manufacturer directly.