Electrode, Circular (Spiral), Scalp And Applicator
The Circular (Spiral) Scalp Electrode and Applicator is a device that attaches to the fetal scalp during labor to provide a direct electrical connection for continuous fetal heart rate monitoring via fetal electrocardiography, offering more reliable signal acquisition than external monitoring. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HGP, regulated under 21 CFR 884.2675, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HGP
- Device Class
- FDA class 2
- Regulation Number
- 884.2675
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Jan 17, 2025 | Substantially Equivalent | Neoventa Medical AB |
| K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | Sep 17, 2003 | Substantially Equivalent | Clinical Innovations, Inc. |
| K003458 | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 | May 03, 2001 | Substantially Equivalent | Clinical Innovations, Inc. |
| K943732 | LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE | Oct 20, 1994 | Substantially Equivalent | Graphic Controls Corp. |
| K910815 | CR SPIRAL ELECTRODE | Dec 10, 1991 | Substantially Equivalent | Neward Enterprises, Inc. |
| K911657 | FETAL SCALP SPIRAL ELECTRODE | Jul 11, 1991 | Substantially Equivalent | Advanced Medical Systems, Inc. |
| K905830 | COMBO FETAL SCALP ELECTRODE/LEGPLATE | Mar 29, 1991 | Substantially Equivalent | Utah Medical Products, Inc. |
| K905130 | FETAL MONITORING SPIRAL ELECTRODE | Jan 29, 1991 | Substantially Equivalent | Graphic Controls Corp. |
| K904745 | MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE | Jan 29, 1991 | Substantially Equivalent | Graphic Controls Corp. |
| K901152 | REDYPLATE DISPOSABLE LEG PLATE | Apr 04, 1990 | Substantially Equivalent | Medical Accessories, Inc. |
| K872057 | FETAL SCALP ELECTRODE | Nov 16, 1987 | Substantially Equivalent | Medical Accessories, Inc. |
| K871079 | FETALFLEX FETAL ELECTRODE | Jul 13, 1987 | Substantially Equivalent | Epcom Medical Systems, Inc. |
| K844608 | SURGICRAFT COPELAND DISPOSABLE | May 01, 1985 | Substantially Equivalent | A.W. Showell (Surgicraft) , Ltd. |
| K822584 | MULTI-PRONG FETAL SCALP ELECTRODE | Feb 24, 1983 | Substantially Equivalent | Kontron Instruments, Inc. |
| K801984 | FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM | Sep 09, 1980 | Substantially Equivalent | Life Support, Inc. |
| K792669 | COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE | Feb 11, 1980 | Substantially Equivalent | Ge Medical Systems Information Technologies |
| K771553 | SPIRAL SCALP ELECTRODE, 14499A | Aug 25, 1977 | Substantially Equivalent | Hewlett-Packard Co. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.