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510(k) K911657

FETAL SCALP SPIRAL ELECTRODE by Advanced Medical Systems, Inc. — Product Code HGP

K911657 is an FDA 510(k) premarket notification submitted by Advanced Medical Systems, Inc. for the device "FETAL SCALP SPIRAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on July 11, 1991. The device falls under product code HGP (Electrode, Circular (Spiral), Scalp And Applicator), a Class II device regulated under 21 CFR 884.2675. Advanced Medical Systems, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1991
Date Received
April 12, 1991
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 by Advanced Medical Systems, Inc.

  • K955931 — MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION) (August 14, 1996)
  • K952031 — ULTRASOUND TRANSDUCER, MODEL US917 (July 18, 1995)
  • K940898 — MODEL IM77 INTRAPARTUM FETAL MONITOR (March 1, 1995)
  • K923335 — ULTRASOUND TRANSUCER, MODEL US915 -- MODIFICATION (July 22, 1994)
  • K932278 — PFM PROFESSIONAL 7000 SPIROMETER (December 17, 1993)
  • K902190 — FETAL PULSE DETECTOR MODEL DOP-1 (October 22, 1990)
  • K894568 — NEW RAD-8 TREATMENT PLANNING COMPUTER SYSTEM (January 9, 1990)
  • K891672 — PUL-TRON 100K PROFESSIONAL SPIROMETER (June 16, 1989)
  • K880756 — MODEL PM-20A PHYSIOLOGICAL MONITOR (September 27, 1988)

Other clearances for product code HGP

  • K243291 — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (January 17, 2025)
  • 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)
  • K905830 — COMBO FETAL SCALP ELECTRODE/LEGPLATE (March 29, 1991)
  • K905130 — FETAL MONITORING SPIRAL ELECTRODE (January 29, 1991)
  • K904745 — MEDI-TRACE(R) 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