Cleared Traditional

K981405 - SYNERGY LT

K981405 is an FDA 510(k) clearance for SYNERGY LT, manufactured by Oxford Instruments, Plc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K981405 · Oxford Instruments, Plc. · Neurology device
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Jul 1998
Decision
87d
Days
Class 2
Risk

K981405 is an FDA 510(k) clearance for the SYNERGY LT. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Oxford Instruments, Plc. (Old Woking , Surrey, GB). The FDA issued a Cleared decision on July 16, 1998 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oxford Instruments, Plc. devices

FDA 510(k) Submission Details - K981405

510(k) Number K981405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1998
Decision Date July 16, 1998
Days to Decision 87 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWF Device Classification - Class 2, Special Controls

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWF Stimulator, Electrical, Evoked Response

All 75
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