SBG · In Situ Polymerizing Peripheral Nerve Cap
Neurology · 21 CFR 882.5260 · Class 2
Overview
| Product Code | SBG |
|---|---|
| Device Name | In Situ Polymerizing Peripheral Nerve Cap |
| Regulation | 21 CFR 882.5260 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
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.
Classification Rationale
Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.
Special Controls
In combination with the general controls of the FD&C Act, the in situ polymerizing peripheral nerve cap is subject to the following special controls:
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252051 | allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) | Tulavi Therapeutics, Inc. | Sep 29, 2025 | SESE |
| DEN230061 | allay Nerve Cap | Tulavi Therapeutics | Jul 16, 2024 | DENG |
Top Applicants
- Tulavi Therapeutics — 1 clearance
- Tulavi Therapeutics, Inc. — 1 clearance
