510(k) DEN230061

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

July 16, 2024

Date Received

September 12, 2023

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

In Situ Polymerizing Peripheral Nerve Cap

Device Class

Class II

Regulation Number

882.5260

Review Panel

NE

Submission Type

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.