HGP · Electrode, Circular (Spiral), Scalp And Applicator
Obstetrics/Gynecology · 21 CFR 884.2675 · Class 2
Overview
| Product Code | HGP |
|---|---|
| Device Name | Electrode, Circular (Spiral), Scalp And Applicator |
| Regulation | 21 CFR 884.2675 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. It establishes electrical contact between fetal skin and an external monitoring device by a shallow subcutaneous puncture of fetal scalp tissue with a curved needle or needles. This generic type of device includes nonreusable spiral electrodes and reusable circular electrodes.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Neoventa Medical AB | Jan 17, 2025 | SESE |
| K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | Clinical Innovations, Inc. | Sep 17, 2003 | SESE |
| K003458 | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 | Clinical Innovations, Inc. | May 3, 2001 | SESE |
| K943732 | LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE | Graphic Controls Corp. | Oct 20, 1994 | SESE |
| K910815 | CR SPIRAL ELECTRODE | Neward Enterprises, Inc. | Dec 10, 1991 | SESE |
| K911657 | FETAL SCALP SPIRAL ELECTRODE | Advanced Medical Systems, Inc. | Jul 11, 1991 | SESE |
| K905830 | COMBO FETAL SCALP ELECTRODE/LEGPLATE | Utah Medical Products, Inc. | Mar 29, 1991 | SESE |
| K905130 | FETAL MONITORING SPIRAL ELECTRODE | Graphic Controls Corp. | Jan 29, 1991 | SESE |
| K904745 | MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE | Graphic Controls Corp. | Jan 29, 1991 | SESE |
| K901152 | REDYPLATE DISPOSABLE LEG PLATE | Medical Accessories, Inc. | Apr 4, 1990 | SESE |
| K872057 | FETAL SCALP ELECTRODE | Medical Accessories, Inc. | Nov 16, 1987 | SESE |
| K871079 | FETALFLEX FETAL ELECTRODE | Epcom Medical Systems, Inc. | Jul 13, 1987 | SESE |
| K844608 | SURGICRAFT COPELAND DISPOSABLE | A.W. Showell (Surgicraft) , Ltd. | May 1, 1985 | SESE |
| K822584 | MULTI-PRONG FETAL SCALP ELECTRODE | Kontron Instruments, Inc. | Feb 24, 1983 | SESE |
| K801984 | FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM | Life Support, Inc. | Sep 9, 1980 | SESE |
| K792669 | COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE | Ge Medical Systems Information Technologies | Feb 11, 1980 | SESE |
| K771553 | SPIRAL SCALP ELECTRODE, 14499A | Hewlett-Packard Co. | Aug 25, 1977 | SESE |
Top Applicants
- Graphic Controls Corp. — 3 clearances
- Clinical Innovations, Inc. — 2 clearances
- Medical Accessories, Inc. — 2 clearances
- A.W. Showell (Surgicraft) , Ltd. — 1 clearance
- Advanced Medical Systems, Inc. — 1 clearance
