Cleared Special

K251957 - Coaptium Connect with Tissium Light (FDA 510(k) Clearance)

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

K251957 · Tissium SA · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2025
Decision
75d
Days
Class 2
Risk

K251957 is an FDA 510(k) clearance 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 Cleared decision on September 8, 2025 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5270 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tissium SA devices

Submission Details

510(k) Number K251957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2025
Decision Date September 08, 2025
Days to Decision 75 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 148d · This submission: 75d
Pathway characteristics
Modification to existing cleared device.

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.