FDA.reportPublic FDA data

Electrosurgical handpiece, reusable

Definition
A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a reusable device.
GUDID devices
151
Last updated
2026-10-04 01:13:38

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05430003362112WAW SLIM HANDPIECEDevroye Instruments Belgium12026-09-21
05430003362242WAW CHARGING STATIONDevroye Instruments Belgium32026-09-21
05430003362259WAW Duo FUE SystemDevroye Instruments Belgium22026-09-21
05430003362280WAW SOFTWAREDevroye Instruments BelgiumV1.x.z2026-09-21
00821925011410DIEGOGyrus ACMI, LLC703390012016-10-12
00821925011441DIEGOGyrus ACMI, LLC703380002017-05-11
00821925028746DiegoGyrus ACMI, LLC703390002016-10-06
00810000520701Sensimatic™PARKELL, INC.D6332018-09-14
00810014633381SurgyCutU.S. SURGITECH INC.790-2062019-03-06
00821925034006DiegoGyrus ACMI, LLC703380032016-10-12
00821925034143DiegoGyrus ACMI, LLC703380082016-10-12
00821925034457DiegoGyrus ACMI, LLC703380072016-10-06
00821925034488DiegoGyrus ACMI, LLC703380092016-10-12
00841494101121IEC 1-Buttom Fingerswitch HandpieceCynosure, LLCIEC-X1FHPA2016-09-19
008414941015653-BUTTON FingerSwitch BLADE HandpieceCynosure, LLCIEC-X3FHPB2016-09-21
00841494103439HANDPIECECynosure, LLCIEC-XLP12016-09-21
00841494103460IEC FOOT-CONTROLLED HPCynosure, LLCIEC-XHP12016-09-21
00841494103897MicroInsulated Needle HandpieceCynosure, LLCXH1362016-09-21
00841494103903MicroInsualted Needle HandpieceCynosure, LLCIEC-XH1362016-09-21
00841494104467RODIN MICROSURGERY HANDPIECECynosure, LLCXRHP2016-09-21
00841494104474RODIN MICROSURGERY HANDPIECECynosure, LLCIEC-XRHPC2016-09-21
008414941066211-Button Fingerswitch HandpieceCynosure, LLCXKO12016-09-21
00860010385609PlasmaMDMed Pen Concepts LLCPlasmaMD2024-01-10
00860010385616Plasma+Med Pen Concepts LLCPlasma+2024-01-10
08800016000436RM STAR EX with RMS NeedleBOMTECH ELECTRONICS CO., LTD.Electrosurgical Cutting and Coagulation Device and2026-04-29
10884521199392LigaSureCovidien LPLF3225C2017-03-22
10884521780552LigaSureCovidien LPLF3225C2018-12-09
20653405014376CONMEDConmed Corporation7142016-09-24
30653405036733DetachaTipConmed Corporation1-10102016-09-24
30653405036764DETACHATIPConmed Corporation1-10152016-09-24
30653405036818DETACHATIPConmed Corporation1-10242016-09-24
30653405061643DetachaTipConmed Corporation3-10182016-09-24
EAMIESI12100Soft InsertsAMI Agency for Medical Innovations GmbHESI12102019-04-05
05430003362006WAW WIRELESS HANDPIECEDevroye Instruments Belgium22025-05-09
05430003362013WAW WIRED HANDPIECEDevroye Instruments Belgium12025-05-09
05430003362020WAW PEDALDevroye Instruments Belgium12025-05-09
05430003362037WAW CHARGING STATIONDevroye Instruments Belgium22025-05-09
05430003362044WAW Duo FUE SystemDevroye Instruments Belgium12025-05-09
05430003362051EXTERNAL SLEEVE SUPPORT BOXDevroye Instruments Belgium12025-05-09
05430003362068WAW SOFTWAREDevroye Instruments Belgium0.1.352025-05-09
05430003362228PUNCH SUPPORT BOXDevroye Instruments Belgium12025-05-09
00821925026902DIEGOGyrus ACMI, LLC703390512024-11-26
00821925026919DIEGOGyrus ACMI, LLC703390532024-11-26
00821925026933DIEGOGyrus ACMI, LLC70339054R2024-11-26
08809581025837Plaxpot Multi Plasma GCS Co., Ltd.GPX-20002024-11-14
00821925011427DIEGOGyrus ACMI, LLC703390502024-07-25
00821925026599DIEGOGyrus ACMI, LLC70339050R2024-07-25
00821925026926DIEGOGyrus ACMI, LLC703390542024-07-25
04048551313442ROTATIPKarl Storz GmbH & Co. KG231512018-09-04
04048551323946CLICKLINEKarl Storz GmbH & Co. KG331492018-07-21
04048551324332CLICKLINEKarl Storz GmbH & Co. KG331482018-07-21
04048551325209ROBIKarl Storz GmbH & Co. KG381512016-09-23
04048551325223CLICKLINEKarl Storz GmbH & Co. KG33149P2016-09-23
04048551328866ROBIKarl Storz GmbH & Co. KG38151P2016-09-23
04048551391716CLICKLINEKarl Storz GmbH & Co. KG33151P2019-02-23
04048551095324TAKE-APARTKarl Storz GmbH & Co. KG26167FGR2016-09-23
04048551102886TAKE-APARTKarl Storz GmbH & Co. KG26184HM2016-09-23
04048551102947TAKE-APARTKarl Storz GmbH & Co. KG26184HR2016-09-23
04048551104040TAKE-APARTKarl Storz GmbH & Co. KG26196HM2016-09-23
04048551104064TAKE-APARTKarl Storz GmbH & Co. KG26196HR2016-09-23
04048551125038CLICKLINEKarl Storz GmbH & Co. KG33121W2016-09-23
04048551125045CLICKLINEKarl Storz GmbH & Co. KG331222016-09-23
04048551125052CLICKLINEKarl Storz GmbH & Co. KG331232016-09-23
04048551125113CLICKLINEKarl Storz GmbH & Co. KG331262016-09-23
04048551001097CLICKLINEKarl Storz GmbH & Co. KG331212016-09-23
04048551009369CLICKLINEKarl Storz GmbH & Co. KG331512016-09-23
04048551009376CLICKLINEKarl Storz GmbH & Co. KG331522016-09-23
04048551009383CLICKLINEKarl Storz GmbH & Co. KG331532016-09-23
04048551009390CLICKLINEKarl Storz GmbH & Co. KG331562016-09-23
04048551066737TAKE-APARTKarl Storz GmbH & Co. KG26284HM2016-09-23
04048551067086TAKE-APARTKarl Storz GmbH & Co. KG26296HM2016-09-23
04048551067109TAKE-APARTKarl Storz GmbH & Co. KG26296HR2016-09-23
00811099014294ReNew XR Handpiece with Reference Length MarkingsMICROLINE SURGICAL, INC.3944M2024-05-03
00081109901429ReNew XR Handpiece with Reference Length MarkingsMICROLINE SURGICAL, INC.3944M2024-05-03
00811099014256ReNew XR Handpiece with Reference Length MarkingsMICROLINE SURGICAL, INC.3943M2024-05-03
00811099014263ReNew XR Handpiece with Reference Length MarkingsMICROLINE SURGICAL, INC.3941M2024-05-03
00811099014270ReNew XR Handpiece with Reference Length MarkingsMICROLINE SURGICAL, INC.3942M2024-05-03
00811099014287ReNew XR Handpiece with Reference Length MarkingsMICROLINE SURGICAL, INC.3946M2024-05-03
00811099014300ReNew XR Handpiece with Reference Length MarkingsMICROLINE SURGICAL, INC.3945M2024-05-03
10885403052620V. MuellerSTERIS CORPORATIONLA81072016-10-04