K252051 is an FDA 510(k) clearance for the allay Nerve Cap (TL5515-1). This device is classified as a In Situ Polymerizing Peripheral Nerve Cap (Class II - Special Controls, product code SBG).
Submitted by Tulavi Therapeutics, Inc. (Los Gatos, US). The FDA issued a Cleared decision on September 29, 2025, 90 days after receiving the submission on July 1, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5260. 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..
| 510(k) Number | K252051 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2025 |
| Decision Date | September 29, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | SBG - In Situ Polymerizing Peripheral Nerve Cap |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5260 |
| Definition | 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. |