FSE Cables SBT-7012
FSE Cables SBT-7012 is a Class II device made by Clinical Innovations, LLC, cleared under FDA 510(k) K030691 on 17 Sep 2003 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 00814247020536), active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00814247020536 | Date1 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK030691 | Date17 Sep 2003 | StatusActive |
Official records
- AccessGUDID record 00814247020536
- FDA 510(k) database K030691
Across registries
- FDA 510(k) K030691 decided 17 Sep 2003 Active
- FDA GUDID UDI-DI 00814247020536 listed 1 Sep 2016 Listed
Recalls
-
- Ongoing Z-0908-2023
Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.
-
- Terminated Z-1250-2019
During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
Timeline
- Cleared FDA 510(k) K030691
- Listed FDA GUDID 00814247020536
- Recall initiated FDA recalls Z-1250-2019
- Recall initiated FDA recalls Z-0908-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- FSE Cables
- Generic name
- Foetal scalp electrode, spiral
- Model / reference
- SBT-7012
- Primary DI / UDI-DI
- 00814247020536
- 510(k) Number
- FDA product code
- HGP
- GMDN term
- Foetal scalp electrode, spiral
- Device class
- Class II
- Regulation number
- 884.2675
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HGP (Electrode, Circular (Spiral), Scalp And Applicator).
- FETAL SCALP SPIRAL ELECTRODE by Advanced Medical Systems, Inc.
- FETAL MONITORING SPIRAL ELECTRODE by Graphic Controls Corp.
- LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE by Graphic Controls Corp.
- FETALFLEX FETAL ELECTRODE by Epcom Medical Systems, Inc.
- COMBO FETAL SCALP ELECTRODE/LEGPLATE by Utah Medical Products, Inc.
- CR SPIRAL ELECTRODE by Neward Enterprises, Inc.
- MULTI-PRONG FETAL SCALP ELECTRODE by Kontron Instruments, Inc.
- 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.