Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart C — Obstetrical and Gynecological Monitoring Devices](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices) → [21 CFR 884.2675](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2675) → HGP — Electrode, Circular (Spiral), Scalp And Applicator # HGP · Electrode, Circular (Spiral), Scalp And Applicator _Obstetrics/Gynecology · 21 CFR 884.2675 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP ## Overview - **Product Code:** HGP - **Device Name:** Electrode, Circular (Spiral), Scalp And Applicator - **Regulation:** [21 CFR 884.2675](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2675) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **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](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K243291.md) | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Neoventa Medical AB | Jan 17, 2025 | SESE | | [K030691](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K030691.md) | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | Clinical Innovations, Inc. | Sep 17, 2003 | SESE | | [K003458](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K003458.md) | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 | Clinical Innovations, Inc. | May 3, 2001 | SESE | | [K943732](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K943732.md) | LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE | Graphic Controls Corp. | Oct 20, 1994 | SESE | | [K910815](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K910815.md) | CR SPIRAL ELECTRODE | Neward Enterprises, Inc. | Dec 10, 1991 | SESE | | [K911657](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K911657.md) | FETAL SCALP SPIRAL ELECTRODE | Advanced Medical Systems, Inc. | Jul 11, 1991 | SESE | | [K905830](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K905830.md) | COMBO FETAL SCALP ELECTRODE/LEGPLATE | Utah Medical Products, Inc. | Mar 29, 1991 | SESE | | [K905130](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K905130.md) | FETAL MONITORING SPIRAL ELECTRODE | Graphic Controls Corp. | Jan 29, 1991 | SESE | | [K904745](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K904745.md) | MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE | Graphic Controls Corp. | Jan 29, 1991 | SESE | | [K901152](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K901152.md) | REDYPLATE DISPOSABLE LEG PLATE | Medical Accessories, Inc. | Apr 4, 1990 | SESE | | [K872057](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K872057.md) | FETAL SCALP ELECTRODE | Medical Accessories, Inc. | Nov 16, 1987 | SESE | | [K871079](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K871079.md) | FETALFLEX FETAL ELECTRODE | Epcom Medical Systems, Inc. | Jul 13, 1987 | SESE | | [K844608](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K844608.md) | SURGICRAFT COPELAND DISPOSABLE | A.W. Showell (Surgicraft) , Ltd. | May 1, 1985 | SESE | | [K822584](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K822584.md) | MULTI-PRONG FETAL SCALP ELECTRODE | Kontron Instruments, Inc. | Feb 24, 1983 | SESE | | [K801984](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K801984.md) | FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM | Life Support, Inc. | Sep 9, 1980 | SESE | | [K792669](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K792669.md) | COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE | Ge Medical Systems Information Technologies | Feb 11, 1980 | SESE | | [K771553](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K771553.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com