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Synergy LT

by Oxford Instruments, Plc. 510(k)

Active United States

510(k) K981405

Overview

The Synergy LT is an electrical stimulator device used for evoked response measurements in neurological applications. It is classified as a Class 2 medical device with product code GWF and is designed to generate electrical responses for diagnostic purposes in neurology.

The Synergy LT is supplied by Oxford Instruments, Plc. and received FDA 510(k) clearance on July 16, 1998, with the clearance number K981405. It is regulated under number 882.1870 and was reviewed by the Neurology advisory committee. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981405 Date16 Jul 1998ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GWF
Device Class
Class II
Regulation
21 CFR Part 882.1870
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Oxford Instruments, Plc.

Questions

  • What is the Synergy LT used for?

    The Synergy LT is an electrical stimulator device designed to generate electrical responses for diagnostic purposes in neurology, specifically for evoked response measurements.

  • Is the Synergy LT a single-use device or reusable?

    The device data does not specify whether the Synergy LT is single-use or reusable, so this information should be confirmed with the manufacturer before use.

  • What regulatory approvals does the Synergy LT have?

    The Synergy LT received FDA 510(k) clearance on July 16, 1998, with clearance number K981405, and is classified as a Class 2 medical device with product code GWF.

  • What are the storage conditions for the Synergy LT?

    The device data does not provide specific information regarding storage conditions for the Synergy LT, so this information should be obtained from the manufacturer.