Corometrics-Push Button Spiral Electrode
by GE Medical Systems Information Technologies
510(k) K792669
Corometrics-Push Button Spiral Electrode is a Class II device made by GE Medical Systems Information Technologies, cleared under FDA 510(k) K792669 on 11 Feb 1980, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792669 | Date11 Feb 1980 | StatusActive |
Official records
- FDA 510(k) database K792669
Recalls
-
- Terminated Z-0330-2013
Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
Timeline
- Cleared FDA 510(k) K792669
- Recall initiated FDA recalls Z-0330-2013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HGP
- Device class
- Class II
- Regulation
- 21 CFR Part 884.2675
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K792669
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Vital Signs™ 7000AAO | 7000AAO / 7000AAO | 10889483588406 | — | On the market |
Similar devices
Other devices filed under FDA product code HGP (Electrode, Circular (Spiral), Scalp And Applicator).
- COMBO FETAL SCALP ELECTRODE/LEGPLATE by Utah Medical Products, Inc.
- CR SPIRAL ELECTRODE by Neward Enterprises, Inc.
- SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 by Clinical Innovations, LLC
- MULTI-PRONG FETAL SCALP ELECTRODE by Kontron Instruments, Inc.
- Medi-Trace Fetal Monitoring Spiral Electrode by Graphic Controls Corp.
- SPIRAL SCALP ELECTRODE, 14499A by Hewlett-Packard Co.
- FETAL SCALP ELECTRODE by Medical Accessories, Inc.
- FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM by Life Support, Inc.
- Kendall 31481396 by Cardinal Health 200, LLC
- REDYPLATE DISPOSABLE LEG PLATE by Medical Accessories, Inc.
Other devices from GE Medical Systems Information Technologies, Inc.
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