FDA.reportPublic FDA data

GYRUS MEDICAL LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96170703002807134GYRUS MEDICAL LTD.1N2026-01-01FORTRAN RD., ST. MELLONS CARDIFF Wales GB CF3 0LT
96170703002807134GYRUS MEDICAL LTD.1N2020-04-25FORTRAN RD., ST. MELLONS CARDIFF Wales GB CF3 0LT

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2015551758298472K994418VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH2000-01-24
2015551128464271K994166GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODEKNS1999-12-27
2015551474560396K993749GYRUS HYSTEROSCOPIC RESECTOSCOPEHIH1999-12-03
2015551405968276K992901GYNECARE VERSAPOINT G-VAP ELECTRODEHIH2000-01-18
2015551818571455K992876VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEMHRX1999-09-24
2015551082884604K992406VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEMGEI1999-08-06
2015551341830581K990628GYRUS ENDOUROLOGY SYSTEMKNS1999-06-29
2015551591051875K982771GYRUS HYSTEROSCOPIC RESECTOSCOPEHIH1999-01-21
2015551392478559K982738VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)HIH1999-03-01
2015551418005060K974022VAPRGEI1998-01-12
2015551386802148K963783MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USEGEI1996-11-25
2015551386528750K962482SCUBA SYSTEMHIH1996-11-01
2015551864541137K182587Device Electrosurgical Generator ESG-150GEI2018-11-29
2015551160246275K180200ESG-300, APU-300, Pressure Reducer, MAPC ProbesGEI2018-04-26
2015551756040203K161038PK MorcellatorGEI2016-10-07
2015551188245836K160053Monopolar single-use HF cableGEI2016-05-06
2015551475553173K143475VAPR Tripolar Suction ElectrodeGEI2015-04-03
2015551123869569K142525PK Lap LoopHIN2014-11-21
2015552036354703K140896VAPR ARCTIC SUCTION ELECTRODEGEI2014-08-05
2015551216068816K122605PKS BILLHIN2012-12-05
2015551957192776K122425VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECTGEI2012-11-05
2015551404376727K120095SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HANDGEI2012-04-06
2015551624506152K113545VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HANGEI2012-02-27
2015551378455483K111751VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERSHIN2011-12-02
2015551204825197K100816PK SUPERPULSE SYSEM GENERATOR MODEL 744000GEI2010-07-01
2015551884745051K100638VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214GEI2010-06-18
2015551188655660K093181GYRUS ACMI PK BUTTON ELECTRODEFAS2010-02-24
2015551200630584K0826433.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATEGEI2008-12-19
2015552006444531K082054GYRUS ACMI PLASMAKINETIC (PK) SUPERPULSE SYSTEM, MODEL 744000 AND DUAL FOOTSWITCH CONNECTOR CABLE, MODEL 710003GEI2008-08-06
2015551270805141K081954GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLEGEI2008-07-31
2015551619957483K080093PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PKGEI2008-05-02
2015551717930464K050550GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATORGEI2005-11-09
2015551819273596K041285GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)GEI2004-09-10
2015551058198481K041135VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODESHRX2004-05-10
2015551108069051K040302VERSAPOINT RESECTOSCOPIC SYSTEMHIH2004-03-09
2015551293701766K031085GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)GEI2003-07-21
2015551894182355K020067GYRUS ENT SOMNOPLASTY GENERATORGEI2002-04-04
2015551488205394K003569PLASMAKINETIC ENDOUROLOGY SYSTEMKNS2000-12-19
2015551993928481K003060PLASMAKINETIC GENERATORGEI2000-10-31
2015551145286559K002422VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEMGEI2000-08-31
2015551922127312K002402VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEMHRX2000-08-31
2015551049811485K001270GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODEFJL2000-04-28
2015551649802392K000936VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEMGEI2000-04-19
3171241012863693
3171241032835848
3171241057870973
3171241094294354
3171241112698982
3171241143955999
3171241211298399
3171241225220541
3171241225759055
3171241229239467
3171241281096936
3171241332430349
3171241389613904
3171241420139023
3171241429533130
3171241452543935
3171241452894524
3171241488257791
3171241530979395
3171241600566856
3171241680490649
3171241745445067
3171241793899689
3171241897906534
3171241914572610
3171241937758687
3171241938847045
3171241956520506
3171241958172277
3171242040882226

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI252018-11-29
HIH72004-03-09
HIN32014-11-21
HRX32004-05-10
KNS32000-12-19
FAS12010-02-24
FJL12000-04-28

PMN#