Cleared Traditional

K923303 - SAPPHIRE PREMIERE

K923303 is the FDA 510(k) clearance for SAPPHIRE PREMIERE by Medelec , Ltd.. It is a Class 2 Neurology device (product code GWF) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K923303 · Medelec , Ltd. · Neurology device
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Nov 1992
Decision
141d
Days
Class 2
Risk

K923303 is an FDA 510(k) clearance for the SAPPHIRE PREMIERE. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Medelec , Ltd. (Surrey, England Gu22 9ju, GB). The FDA issued a Cleared decision on November 24, 1992 after a review of 141 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medelec , Ltd. devices

Submission Details

510(k) Number K923303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1992
Decision Date November 24, 1992
Days to Decision 141 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 148d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
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