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510(k) K844608

SURGICRAFT COPELAND DISPOSABLE by A.W. Showell (Surgicraft) , Ltd. — Product Code HGP

K844608 is an FDA 510(k) premarket notification submitted by A.W. Showell (Surgicraft) , Ltd. for the device "SURGICRAFT COPELAND DISPOSABLE". The FDA issued a decision of Substantially Equivalent on May 1, 1985. The device falls under product code HGP (Electrode, Circular (Spiral), Scalp And Applicator), a Class II device regulated under 21 CFR 884.2675. A.W. Showell (Surgicraft) , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1985
Date Received
November 27, 1984
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 A.W. Showell (Surgicraft) , Ltd.

  • K853033 — HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM (September 24, 1985)

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)
  • K911657 — FETAL SCALP SPIRAL ELECTRODE (July 11, 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)

FDA data resources