K243291 is an FDA 510(k) clearance for the Goldtrace Fetal Spiral Electrode (FSE) (CNS000004). This device is classified as a Electrode, Circular (spiral), Scalp And Applicator (Class II - Special Controls, product code HGP).
Submitted by Neoventa Medical AB (Mölndal, SE). The FDA issued a Cleared decision on January 17, 2025, 91 days after receiving the submission on October 18, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2675.
| 510(k) Number | K243291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2024 |
| Decision Date | January 17, 2025 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGP - Electrode, Circular (spiral), Scalp And Applicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2675 |