Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (K243291)
Description
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) by Neoventa Medical AB, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243291
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (K243291) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | Clinical Innovations, Inc. | 2003 |
Trace the full predicate network for K243291
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.