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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K161378

joimax Electrosurgical Instruments · Joimax GmbH · decided 2016-11-02 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Legato®JMPH352505Joimax GmbHGEI04250337104070
Legato®JBPH352506Joimax GmbHGEI04250337103820
Vaporflex®JVH25030Joimax GmbHGEI04250337114383
Endovapor®JEVN0001Joimax GmbHGEI04250350109274
Vaporace®/Vaporgrip® Kabel, L 3,0 mVBFC8030Joimax GmbHGEI04250337118312
Legato®JMPP27025*Joimax GmbHGEI04250337115243
Vaporflex®JVC35030Joimax GmbHGEI04250337104049
Vaporflex®JVHP10023Joimax GmbHGEI04250337104032
Vaporflex®JVUH10010Joimax GmbHGEI04250337103899
Vaporflex®JVK1-250Joimax GmbHGEI04250337114406
Vaporflex®JVHS32030Joimax GmbHGEI04250337103882
Vaporflex®JVHS25030Joimax GmbHGEI04250337113867
Vaporflex®JVP25024Joimax GmbHGEI04250337113843
Vaporace® Probe bipolar, Area 320 mm – 3.5 mmJVAPA32035Joimax GmbHGEI04250337118633
Legato®JMPH352504Joimax GmbHGEI04250337103783
Legato®JBPH352505Joimax GmbHGEI04250337103813
Vaporflex®JVHS27527SJoimax GmbHGEI04250337104056
Legato®JRFCP2300Joimax GmbHGEI04250337119999
Vaporflex®JVP27525SJoimax GmbHGEI04250337105169
Vaporace® Probe bipolar, Area 270 mm – 3.5 mmJVAPA27035Joimax GmbHGEI04250337118619
Vaporflex®JVP28024Joimax GmbHGEI04250337116264
Vaporflex®JVHS28030Joimax GmbHGEI04250337116783
Legato®JBPP27025Joimax GmbHGEI04250337116066
Vaporflex®JVC35010Joimax GmbHGEI04250337103905
Vaporace® Probe bipolar, Area 150 mm – 3.5 mmJVAPA15035Joimax GmbHGEI04250337120223