FDA Product Code
FDA Product Code HGP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2675
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) | Neoventa Medical AB | 2025-01-17 | Traditional | PDF ↗ |
| K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | Clinical Innovations, Inc. | 2003-09-17 | Traditional | PDF ↗ |
| K003458 | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 | Clinical Innovations, Inc. | 2001-05-03 | Traditional | PDF ↗ |
| K943732 | LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE | Graphic Controls Corp. | 1994-10-20 | Traditional | PDF ↗ |
| K910815 | CR SPIRAL ELECTRODE | Neward Enterprises, Inc. | 1991-12-10 | Traditional | PDF ↗ |
| K911657 | FETAL SCALP SPIRAL ELECTRODE | Advanced Medical Systems, Inc. | 1991-07-11 | Traditional | PDF ↗ |
| K905830 | COMBO FETAL SCALP ELECTRODE/LEGPLATE | Utah Medical Products, Inc. | 1991-03-29 | Traditional | PDF ↗ |
| K905130 | FETAL MONITORING SPIRAL ELECTRODE | Graphic Controls Corp. | 1991-01-29 | Traditional | PDF ↗ |
| K904745 | MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE | Graphic Controls Corp. | 1991-01-29 | Traditional | PDF ↗ |
| K901152 | REDYPLATE DISPOSABLE LEG PLATE | Medical Accessories, Inc. | 1990-04-04 | Traditional | PDF ↗ |
| K872057 | FETAL SCALP ELECTRODE | Medical Accessories, Inc. | 1987-11-16 | Traditional | PDF ↗ |
| K871079 | FETALFLEX FETAL ELECTRODE | Epcom Medical Systems, Inc. | 1987-07-13 | Traditional | PDF ↗ |
| K844608 | SURGICRAFT COPELAND DISPOSABLE | A.W. Showell (Surgicraft) , Ltd. | 1985-05-01 | Traditional | PDF ↗ |
| K822584 | MULTI-PRONG FETAL SCALP ELECTRODE | Kontron Instruments, Inc. | 1983-02-24 | Traditional | PDF ↗ |
| K801984 | FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM | Life Support, Inc. | 1980-09-09 | Traditional | PDF ↗ |
| K792669 | COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE | Ge Medical Systems Information Technologies | 1980-02-11 | Traditional | PDF ↗ |
| K771553 | SPIRAL SCALP ELECTRODE, 14499A | Hewlett-Packard Co. | 1977-08-25 | Traditional | PDF ↗ |
Product code HGP · Class II · Obstetrics/Gynecology. Data: openFDA.