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Hi-Tops Electrodes 14-8000

by W. J. Medical Instruments, Inc. 510(k)

Active United States

510(k) K935947

Overview

The Hi-Tops Electrodes 14-8000 is a coagulator-cutter, endoscopic, unipolar device and its accessories. It is designed for use in medical procedures requiring cutting and coagulation.

The device is supplied by W. J. Medical Instruments, Inc. and is authorized under FDA 510K clearance. It is intended for use in obstetrics/gynecology settings and is classified as a Class II medical device.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK935947 Date28 Feb 1994ClearedStatusActive

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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KNF
Device Class
Class II
Regulation
21 CFR Part 884.4160
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Other devices from W. J. Medical Instruments, Inc.

Questions

  • What is the Hi-Tops Electrodes 14-8000 used for?

    The Hi-Tops Electrodes 14-8000 is a coagulator-cutter, endoscopic, unipolar device designed for medical procedures requiring cutting and coagulation, specifically intended for use in obstetrics/gynecology settings.

  • How is the Hi-Tops Electrodes 14-8000 supplied?

    The device is supplied by W. J. Medical Instruments, Inc. and is classified as a Class II medical device, authorized under FDA 510K clearance with the K number K935947.

  • What is the regulatory status of the Hi-Tops Electrodes 14-8000?

    The Hi-Tops Electrodes 14-8000 has received FDA 510K clearance, with a decision date of 1994-02-28, and is classified as substantially equivalent under the product code KNF for obstetrics/gynecology procedures.

  • Is the Hi-Tops Electrodes 14-8000 reusable or single-use?

    The device data does not specify whether the Hi-Tops Electrodes 14-8000 is designed for single-use or reuse. This information would need to be obtained directly from the manufacturer or product documentation.