Not Cleared Direct

DEN240066 - COAPTIUM Connect with TISSIUM LIGHT (FDA 510(k) Clearance)

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

DEN240066 · Tissium SA · Neurology device
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Jun 2025
Decision
208d
Days
Class 2
Risk

DEN240066 is an FDA 510(k) submission (not cleared) for the COAPTIUM Connect with TISSIUM LIGHT. Classified as In Situ Polymerizing Peripheral Nerve Repair Device (product code SFD), Class II - Special Controls.

Submitted by Tissium SA (Paris, FR). The FDA issued a Not Cleared (DENG) decision on June 17, 2025 after a review of 208 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5270 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

View all Tissium SA devices

Submission Details

510(k) Number DEN240066 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 21, 2024
Decision Date June 17, 2025
Days to Decision 208 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 148d · This submission: 208d
Pathway characteristics

Device Classification

Product Code SFD In Situ Polymerizing Peripheral Nerve Repair Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5270
Definition An In Situ Polymerizing Peripheral Nerve Repair Device Is Intended For The Sutureless Repair Of Peripheral Nerve Injuries.
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.