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# De Novo Authorization for Allay Nerve Cap
- URL: https://www.fdaweb.com/de-novo-authorization-for-allay-nerve-cap-2/
- Published: 2024-07-22T12:00:00.000Z
- Updated: 2026-09-14T14:36:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157402

FDA has granted Tulavi Therapeutics a *de novo* marketing authorization for its Allay Nerve Cap, described as a fully absorbable *in situ* forming hydrogel that is designed to protect transected nerves, prevent axonal escape, and reduce the risk of neuroma formation. When peripheral nerves are cut during amputation, they attempt to regenerate, and without a distal nerve to regenerate onto, they often develop phantom and residual limb pain for amputees, the company says. The hydrogel is designed to encapsulate the end of a severed nerve to reduce subsequent nerve pain. The procedure is performed without the need for sutures so that procedural time is reduced, and granulomas are prevented, according to the company.