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FSE Cables SBT-7015

by Clinical Innovations, LLC

FSE Cables SBT-7015 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 00814247020550), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K030691

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00814247020550 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK030691 Date17 Sep 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K030691 decided 17 Sep 2003 Active
  • FDA GUDID UDI-DI 00814247020550 listed 1 Sep 2016 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0908-2023 FDA Class II initiated 21 Nov 2022

    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 FDA Class II initiated 25 Jan 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

4 dated events

  1. Cleared FDA 510(k) K030691
  2. Listed FDA GUDID 00814247020550
  3. Recall initiated FDA recalls Z-1250-2019
  4. Recall initiated FDA recalls Z-0908-2023

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
FSE Cables
Generic name
Foetal scalp electrode, spiral
Model / reference
SBT-7015
Primary DI / UDI-DI
00814247020550
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

Related devices

Category: Foetal scalp electrode, spiral

Cleared under the same submission (K030691)

and 6 more cleared under K030691

Similar devices

Other devices filed under FDA product code HGP (Electrode, Circular (Spiral), Scalp And Applicator).

Other devices from Clinical Innovations, LLC

See all devices from Clinical Innovations, LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)