Atlas FDA

HGP

17 FDA 510(k) clearances · Product code

91 daysmedian time to decision
196 days90th percentile
17clearances measured

FDA profile

Official device name
Electrode, Circular (Spiral), Scalp And Applicator
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2675
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2017: 17 · 2018: 44 · 2019: 26 · 2020: 25 · 2021: 33 · 2022: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (K243291)Neoventa Medical AB2025-01-17
FETAL SPIRAL ELECTRODE, MODEL FSE07000 (K030691)Clinical Innovations, Inc.2003-09-17
SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 (K003458)Clinical Innovations, Inc.2001-05-03
LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE (K943732)Graphic Controls Corp.1994-10-20
CR SPIRAL ELECTRODE (K910815)Neward Enterprises, Inc.1991-12-10
FETAL SCALP SPIRAL ELECTRODE (K911657)Advanced Medical Systems, Inc.1991-07-11
COMBO FETAL SCALP ELECTRODE/LEGPLATE (K905830)Utah Medical Products, Inc.1991-03-29
FETAL MONITORING SPIRAL ELECTRODE (K905130)Graphic Controls Corp.1991-01-29
MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE (K904745)Graphic Controls Corp.1991-01-29
REDYPLATE DISPOSABLE LEG PLATE (K901152)Medical Accessories, Inc.1990-04-04
FETAL SCALP ELECTRODE (K872057)Medical Accessories, Inc.1987-11-16
FETALFLEX FETAL ELECTRODE (K871079)Epcom Medical Systems, Inc.1987-07-13
SURGICRAFT COPELAND DISPOSABLE (K844608)A.W. Showell (Surgicraft) , Ltd.1985-05-01
MULTI-PRONG FETAL SCALP ELECTRODE (K822584)Kontron Instruments, Inc.1983-02-24
FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM (K801984)Life Support, Inc.1980-09-09
COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE (K792669)Ge Medical Systems Information Technologies1980-02-11
SPIRAL SCALP ELECTRODE, 14499A (K771553)Hewlett-Packard Co.1977-08-25

Track HGP automatically

Every clearance here is in the API, with alerts when new ones post.