Not Cleared Direct

DEN230061 - allay Nerve Cap (FDA 510(k) Clearance)

Class II Neurology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230061 · Tulavi Therapeutics · Neurology device
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Jul 2024
Decision
308d
Days
Class 2
Risk

DEN230061 is an FDA 510(k) submission (not cleared) for the allay Nerve Cap. Classified as In Situ Polymerizing Peripheral Nerve Cap (product code SBG), Class II - Special Controls.

Submitted by Tulavi Therapeutics (Lost Gatos, US). The FDA issued a Not Cleared (DENG) decision on July 16, 2024 after a review of 308 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5260 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 308 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN230061 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 12, 2023
Decision Date July 16, 2024
Days to Decision 308 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 148d · This submission: 308d
Pathway characteristics

Device Classification

Product Code SBG In Situ Polymerizing Peripheral Nerve Cap
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5260
Definition An In Situ Polymerizing Peripheral Nerve Cap Is A Prescription Use Only Device Composed Of Precursor Materials That Polymerize When Delivered To The End Of A Peripheral Nerve To Function As A Physical Barrier To The Surrounding In Vivo Environment To Reduce The Risk Of Formation Of A Symptomatic Neuroma.
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.