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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2023 | Philips North America Llc Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor.
PN: 989803137631 Open, Classified |
HGP | K030691 |
| Jan 25, 2019 | Philips North America, LLC Fetal Spiral Electrode, Model No. 9898 031 37631 Terminated |
HGP | K030691 |
| Nov 16, 2012 | Vital Signs Devices, a GE Healthcare Company Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0
A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery Terminated |
HGP | K792669 |
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