Product code HGP
- Device name
- Electrode, Circular (Spiral), Scalp And Applicator
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.2675
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Neoventa Medical AB | 2025-01-17 |
| K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | Clinical Innovations, Inc. | 2003-09-17 |
| K003458 | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 | Clinical Innovations, Inc. | 2001-05-03 |
| K943732 | LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE | Graphic Controls Corp. | 1994-10-20 |
| K910815 | CR SPIRAL ELECTRODE | Neward Enterprises, Inc. | 1991-12-10 |
| K911657 | FETAL SCALP SPIRAL ELECTRODE | Advanced Medical Systems, Inc. | 1991-07-11 |
| K905830 | COMBO FETAL SCALP ELECTRODE/LEGPLATE | Utah Medical Products, Inc. | 1991-03-29 |
| K904745 | MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE | Graphic Controls Corp. | 1991-01-29 |
| K905130 | FETAL MONITORING SPIRAL ELECTRODE | Graphic Controls Corp. | 1991-01-29 |
| K901152 | REDYPLATE DISPOSABLE LEG PLATE | Medical Accessories, Inc. | 1990-04-04 |
| K872057 | FETAL SCALP ELECTRODE | Medical Accessories, Inc. | 1987-11-16 |
| K871079 | FETALFLEX FETAL ELECTRODE | Epcom Medical Systems, Inc. | 1987-07-13 |
| K844608 | SURGICRAFT COPELAND DISPOSABLE | A.W. Showell (Surgicraft) , Ltd. | 1985-05-01 |
| K822584 | MULTI-PRONG FETAL SCALP ELECTRODE | Kontron Instruments, Inc. | 1983-02-24 |
| K801984 | FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM | Life Support, Inc. | 1980-09-09 |
| K792669 | COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE | Ge Medical Systems Information Technologies | 1980-02-11 |
| K771553 | SPIRAL SCALP ELECTRODE, 14499A | Hewlett-Packard Co. | 1977-08-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07340154900010 | Goldtrace Fetal Spiral Electrode (FSE) | Neoventa Medical AB | 2026-03-06 |
| 07340154900027 | Goldtrace Fetal Spiral Electrode (FSE) | Neoventa Medical AB | 2026-03-06 |
| 20889483588403 | Vital Signs™ | AirLife Finland Oy | 2025-03-31 |
| 10889483588406 | Vital Signs™ | AirLife Finland Oy | 2025-03-31 |
| 05055270977144 | Rocket | ROCKET MEDICAL PLC | 2023-10-24 |
| 05055270977113 | Rocket | ROCKET MEDICAL PLC | 2023-10-24 |
| 05055270977137 | Rocket | ROCKET MEDICAL PLC | 2023-10-24 |
| 05055270977168 | Rocket | ROCKET MEDICAL PLC | 2023-10-24 |
| 10814247021196 | FSE | CLINICAL INNOVATIONS, LLC | 2023-09-27 |
| 00814247021199 | FSE | CLINICAL INNOVATIONS, LLC | 2023-09-27 |
| 00814247021205 | FSE Cables | CLINICAL INNOVATIONS, LLC | 2023-09-27 |
| 10192253040500 | Kendall | Cardinal Health 200, LLC | 2022-05-27 |
| 50192253021156 | Kendall | Cardinal Health 200, LLC | 2021-02-23 |
| 10192253021158 | Kendall | Cardinal Health 200, LLC | 2021-02-23 |
| 50190752142174 | Vital Signs™ | Vyaire Medical Oy | 2020-12-15 |
| 10190752142176 | Vital Signs™ | AirLife Finland Oy | 2020-12-15 |
| 10192253020977 | Kendall | Cardinal Health 200, LLC | 2020-10-30 |
| 50192253020975 | Kendall | Cardinal Health, Inc. | 2020-10-30 |
| B510FM30001 | ADVANCED FETAL MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| 10885403252204 | N/A | Carefusion Finland 320 Oy | 2016-10-17 |
| 20885403252201 | N/A | Carefusion Finland 320 Oy | 2016-10-17 |
| 20884527002822 | Kendall | Cardinal Health, Inc. | 2016-09-24 |
| 10884527004911 | Kendall | Cardinal Health, Inc. | 2016-09-24 |
| 10884521081123 | Kendall | Cardinal Health, Inc. | 2016-09-24 |
| 20884521081120 | Kendall | Cardinal Health, Inc. | 2016-09-24 |
| 20884527004918 | Kendall | Cardinal Health, Inc. | 2016-09-24 |
| 20884527002815 | Kendall | Cardinal Health, Inc. | 2016-09-24 |
| 50885403248960 | Vital Signs | Carefusion Finland 320 Oy | 2016-09-14 |
| 10885403248962 | Vital Signs | Carefusion Finland 320 Oy | 2016-09-14 |
| 00814247020741 | Goldtrace One | CLINICAL INNOVATIONS, LLC | 2016-09-01 |