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510(k) K243291

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) by Neoventa Medical AB — Product Code HGP

K243291 is an FDA 510(k) premarket notification submitted by Neoventa Medical AB for the device "Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code HGP (Electrode, Circular (Spiral), Scalp And Applicator), a Class II device regulated under 21 CFR 884.2675.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2025
Date Received
October 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Circular (Spiral), Scalp And Applicator
Device Class
Class II
Regulation Number
884.2675
Review Panel
OB
Submission Type

Other clearances for product code HGP

  • K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE07000 (September 17, 2003)
  • K003458 — SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 (May 3, 2001)
  • K943732 — LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE (October 20, 1994)
  • K910815 — CR SPIRAL ELECTRODE (December 10, 1991)
  • K911657 — FETAL SCALP SPIRAL ELECTRODE (July 11, 1991)
  • K905830 — COMBO FETAL SCALP ELECTRODE/LEGPLATE (March 29, 1991)
  • K904745 — MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE (January 29, 1991)
  • K905130 — FETAL MONITORING SPIRAL ELECTRODE (January 29, 1991)
  • K901152 — REDYPLATE DISPOSABLE LEG PLATE (April 4, 1990)
  • K872057 — FETAL SCALP ELECTRODE (November 16, 1987)

FDA data resources