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KSEA Bipolar Coagulating Electrodes

by Karl Storz Endoscopy 510(k)

Active United States

510(k) K001630

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001630 Date19 Jul 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
GWG
Device Class
Class II
Regulation
21 CFR Part 882.1480
Advisory Committee
Neurology
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 KSEA Bipolar Coagulating Electrodes are bipolar resection electrodes used in operative hysteroscopy. The applied current is restricted to the two distal electrodes in the surgeon's field of vision.

These electrodes are supplied as Class II devices under product code GWG with FDA 510(k) clearance K001630, issued on July 19, 2000. They are classified as Endoscope, Neurological devices under regulation number 882.1480.

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