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Ksea Monopolar Vaporization Electrodes

by Karl Storz Endoscopy-America, Inc. 2 variants

510(k) K001740

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 NumberK001740 Date22 Aug 2000ClearedStatusActive

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  • Withdrawn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
HIH
Device Class
Class II
Regulation
21 CFR Part 884.1690
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Ksea Monopolar Vaporization Electrodes are surgical instruments designed for use in hysteroscopic procedures. These devices are utilized by qualified surgeons to perform tissue vaporization and resection.

These electrodes are supplied as sterile, single-use instruments intended for operation in clinical settings. The device is regulated under FDA 510(k) clearance and is classified as a hysteroscope accessory.

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Questions

AI-generated answers, 21 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 are Ksea Monopolar Vaporization Electrodes used for?

    These electrodes are surgical instruments specifically designed for use by qualified surgeons during hysteroscopic procedures to perform tissue vaporization and resection.

  • Are these electrodes reusable?

    No, these devices are supplied as single-use instruments. This ensures that each procedure is performed with a sterile, pristine device, eliminating the need for reprocessing.

  • How are these electrodes supplied to the clinical setting?

    The electrodes are supplied as sterile instruments, intended for immediate use in clinical settings to maintain the necessary standards for surgical procedures.

  • What is the regulatory status of this device?

    The Ksea Monopolar Vaporization Electrodes are regulated under FDA 510(k) clearance and are classified as a hysteroscope accessory.