Panels › Obstetrics/Gynecology › Product code HGP · Class 2
Electrode, Circular (Spiral), Scalp And Applicator
Regulation 884.2675
0510(k)s in 12 months (17 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in HGP
| Company | 510(k)s | Recalls |
|---|---|---|
| Graphic Controls Corp. | 3 | 0 |
| Clinical Innovations, Inc. | 2 | 0 |
| Medical Accessories, Inc. | 2 | 0 |
| Philips North America Llc | 0 | 2 |
| A.W. Showell (Surgicraft) , Ltd. | 1 | 0 |
| Advanced Medical Systems, Inc. | 1 | 0 |
| Epcom Medical Systems, Inc. | 1 | 0 |
| Ge Medical Systems Information Technologies | 1 | 0 |
| Hewlett-Packard Co. | 1 | 0 |
| Kontron Instruments, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 17, 2025 | K243291 | Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) Neoventa Medical AB, SE | HGP |
| Sep 17, 2003 | K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 Clinical Innovations, Inc. | HGP |
| May 3, 2001 | K003458 | SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 Clinical Innovations, Inc. | HGP |
| Oct 20, 1994 | K943732 | LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE Graphic Controls Corp. | HGP |
| Dec 10, 1991 | K910815 | CR SPIRAL ELECTRODE Neward Enterprises, Inc. | HGP |
| Jul 11, 1991 | K911657 | FETAL SCALP SPIRAL ELECTRODE Advanced Medical Systems, Inc. | HGP |
| Mar 29, 1991 | K905830 | COMBO FETAL SCALP ELECTRODE/LEGPLATE Utah Medical Products, Inc. | HGP |
| Jan 29, 1991 | K905130 | FETAL MONITORING SPIRAL ELECTRODE Graphic Controls Corp. | HGP |
| Jan 29, 1991 | K904745 | MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE Graphic Controls Corp. | HGP |
| Apr 4, 1990 | K901152 | REDYPLATE DISPOSABLE LEG PLATE Medical Accessories, Inc. | HGP |
| Nov 16, 1987 | K872057 | FETAL SCALP ELECTRODE Medical Accessories, Inc. | HGP |
| Jul 13, 1987 | K871079 | FETALFLEX FETAL ELECTRODE Epcom Medical Systems, Inc. | HGP |
| May 1, 1985 | K844608 | SURGICRAFT COPELAND DISPOSABLE A.W. Showell (Surgicraft) , Ltd., GB | HGP |
| Feb 24, 1983 | K822584 | MULTI-PRONG FETAL SCALP ELECTRODE Kontron Instruments, Inc. | HGP |
| Sep 9, 1980 | K801984 | FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM Life Support, Inc. | HGP |
| Feb 11, 1980 | K792669 | COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE Ge Medical Systems Information Technologies | HGP |
| Aug 25, 1977 | K771553 | SPIRAL SCALP ELECTRODE, 14499A Hewlett-Packard Co. | HGP |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.