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FDA 510(k)

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)

K-Number: K243291 · 2025-01-17

ApplicantNeoventa Medical AB
Decision Date2025-01-17
Product CodeHGP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) is the device name listed in this FDA 510(k) record. The listed applicant is Neoventa Medical AB. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K243291. The device is classified under product code HGP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)?

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Neoventa Medical AB. The 510(k) number is K243291.

When did Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) receive FDA 510(k) clearance?

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) received FDA 510(k) clearance on 2025-01-17, under 510(k) number K243291.

Who is the listed applicant for Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)?

The FDA 510(k) record lists Neoventa Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)?

The FDA product code for Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) is HGP.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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