Atlas FDA

FETAL SCALP SPIRAL ELECTRODE

FDA 510(k) clearance K911657 · decided 1991-07-11

Clearance details

K-number
K911657
Device name
FETAL SCALP SPIRAL ELECTRODE
Applicant
Advanced Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
1991-04-12
Decision date
1991-07-11
Days to decision
90 days
Clearance type
Traditional
Product code
HGP
Device class
2
Regulation number
884.2675
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Hamden, CT, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (K243291)Neoventa Medical AB2025-01-17
FETAL SPIRAL ELECTRODE, MODEL FSE07000 (K030691)Clinical Innovations, Inc.2003-09-17
SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 (K003458)Clinical Innovations, Inc.2001-05-03
LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE (K943732)Graphic Controls Corp.1994-10-20
CR SPIRAL ELECTRODE (K910815)Neward Enterprises, Inc.1991-12-10
COMBO FETAL SCALP ELECTRODE/LEGPLATE (K905830)Utah Medical Products, Inc.1991-03-29
FETAL MONITORING SPIRAL ELECTRODE (K905130)Graphic Controls Corp.1991-01-29
MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE (K904745)Graphic Controls Corp.1991-01-29
REDYPLATE DISPOSABLE LEG PLATE (K901152)Medical Accessories, Inc.1990-04-04
FETAL SCALP ELECTRODE (K872057)Medical Accessories, Inc.1987-11-16
FETALFLEX FETAL ELECTRODE (K871079)Epcom Medical Systems, Inc.1987-07-13
SURGICRAFT COPELAND DISPOSABLE (K844608)A.W. Showell (Surgicraft) , Ltd.1985-05-01

Recalls involving this device

No recalls on record reference this clearance.