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HGP — Electrode, Circular (Spiral), Scalp And Applicator Class II

FDA Device Classification

Classification Details

Product Code
HGP
Device Class
Class II
Regulation Number
884.2675
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243291neoventa medicalGoldtrace Fetal Spiral Electrode (FSE) (CNS000004)January 17, 2025
K030691clinical innovationsFETAL SPIRAL ELECTRODE, MODEL FSE07000September 17, 2003
K003458clinical innovationsSOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000May 3, 2001
K943732graphic controlsLIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCEOctober 20, 1994
K910815neward enterprisesCR SPIRAL ELECTRODEDecember 10, 1991
K911657advanced medical systemsFETAL SCALP SPIRAL ELECTRODEJuly 11, 1991
K905830utah medical productsCOMBO FETAL SCALP ELECTRODE/LEGPLATEMarch 29, 1991
K904745graphic controlsMEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODEJanuary 29, 1991
K905130graphic controlsFETAL MONITORING SPIRAL ELECTRODEJanuary 29, 1991
K901152medical accessoriesREDYPLATE DISPOSABLE LEG PLATEApril 4, 1990
K872057medical accessoriesFETAL SCALP ELECTRODENovember 16, 1987
K871079epcom medical systemsFETALFLEX FETAL ELECTRODEJuly 13, 1987
K844608a.w. showell (surgicraft)SURGICRAFT COPELAND DISPOSABLEMay 1, 1985
K822584kontron instrumentsMULTI-PRONG FETAL SCALP ELECTRODEFebruary 24, 1983
K801984life supportFE-3000 FETAL ELECTRODE, SPIRAL SYSTEMSeptember 9, 1980
K792669ge medical systems information technologiesCOROMETRICS-PUSH BUTTON SPIRAL ELECTRODEFebruary 11, 1980
K771553hewlett-packardSPIRAL SCALP ELECTRODE, 14499AAugust 25, 1977