K252051
- 510(k) number
- K252051
- Device name
- allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)
- Applicant
- Tulavi Therapeutics, Inc. CA · US
- Product code
- SBG — In Situ Polymerizing Peripheral Nerve Cap
- Decision date
- 2025-09-29
- Date received
- 2025-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252051.pdf
Official FDA record: K252051
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.