510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243291Substantially Equivalent

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)

Neoventa Medical AB, Mölndal, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243291 is the FDA 510(k) clearance record for Goldtrace Fetal Spiral Electrode (FSE) (CNS000004), a class II device, cleared for Neoventa Medical AB on under FDA product code HGP (Electrode, Circular (Spiral), Scalp And Applicator). FDA records list one 510(k) clearance for Neoventa Medical AB. As of , FDA records show no recalls naming K243291.

Clearance record

Decision date
Received
(91 days to decision)
Product code
HGP Electrode, Circular (Spiral), Scalp And Applicator
Regulation
21 CFR 884.2675
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Neoventa Medical AB Norra Ågatan 32, Mölndal, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HGP

Trailing 12 months

FDA records hold no clearances under product code HGP in the trailing twelve months.

FDA records show no clearances under product code HGP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HGP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260