Electrode, Circular (Spiral), Scalp And Applicator
FDA product code HGP · Class II (moderate risk) · 21 CFR 884.2675 · Obstetrics/Gynecology
17510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Graphic Controls Corp. 3
- Medical Accessories, Inc. 2
- Clinical Innovations, LLC 2
- Hewlett-Packard Co. 1
- Ge Medical Systems Information Technologies 1
- Life Support, Inc. 1
- Kontron Instruments, Inc. 1
- A.W. Showell (Surgicraft) , Ltd. 1
- Epcom Medical Systems, Inc. 1
- Utah Medical Products, Inc. 1
- Advanced Medical Systems, Inc. 1
- Neward Enterprises, Inc. 1
- Neoventa Medical AB 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)HGP · Traditional | Neoventa Medical AB | 01/17/2025SE |
| K030691 | Fetal Spiral Electrode, Model FSE07000HGP · Traditional | Clinical Innovations, Inc. | 09/17/2003SE |
| K003458 | Soft Beat Fetal Heart Rate Electrode Model SBT-7000HGP · Traditional | Clinical Innovations, Inc. | 05/03/2001SE |
| K943732 | Life Trace Fetal Spiral Electrode with Maternal ReferenceHGP · Traditional | Graphic Controls Corp. | 10/20/1994SE |
| K910815 | CR Spiral ElectrodeHGP · Traditional | Neward Enterprises, Inc. | 12/10/1991SE |
| K911657 | Fetal Scalp Spiral ElectrodeHGP · Traditional | Advanced Medical Systems, Inc. | 07/11/1991SE |
| K905830 | Combo Fetal Scalp Electrode/LegplateHGP · Traditional | Utah Medical Products, Inc. | 03/29/1991SE |
| K905130 | Fetal Monitoring Spiral ElectrodeHGP · Traditional | Graphic Controls Corp. | 01/29/1991SE |
| K904745 | Medi-Trace(R) Fetal Monitoring Spiral ElectrodeHGP · Traditional | Graphic Controls Corp. | 01/29/1991SE |
| K901152 | Redyplate Disposable Leg PlateHGP · Traditional | Medical Accessories, Inc. | 04/04/1990SE |
| K872057 | Fetal Scalp ElectrodeHGP · Traditional | Medical Accessories, Inc. | 11/16/1987SE |
| K871079 | Fetalflex Fetal ElectrodeHGP · Traditional | Epcom Medical Systems, Inc. | 07/13/1987SE |
| K844608 | Surgicraft Copeland DisposableHGP · Traditional | A.W. Showell (Surgicraft) , Ltd. | 05/01/1985SE |
| K822584 | Multi-Prong Fetal Scalp ElectrodeHGP · Traditional | Kontron Instruments, Inc. | 02/24/1983SE |
| K801984 | FE-3000 Fetal Electrode, Spiral SystemHGP · Traditional | Life Support, Inc. | 09/09/1980SE |
| K792669 | Corometrics-Push Button Spiral ElectrodeHGP · Traditional | Ge Medical Systems Information Technologies | 02/11/1980SE |
| K771553 | Spiral Scalp Electrode, 14499AHGP · Traditional | Hewlett-Packard Co. | 08/25/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0908-2023 Class II | Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate…Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical… | Philips North America Llc | 11/21/2022Open, Classified |
| Z-1250-2019 Class II | Fetal Spiral Electrode, Model No. 9898 031 37631During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the… | Philips North America, LLC | 01/25/2019Terminated |
| Z-0330-2013 Class II | Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular…Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot… | Vital Signs Devices, a GE Healthcare Company | 10/16/2012Terminated |