← Product Code [JXI](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI) · K850785

# FASTUBE NERVE REGENERATION DEVICE (K850785)

_Research Medical, Inc. · JXI · Jul 10, 1985 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K850785

## Device Facts

- **Applicant:** Research Medical, Inc.
- **Product Code:** [JXI](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI.md)
- **Decision Date:** Jul 10, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5275
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K850785](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/JXI/K850785)

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