đź“‹ FDA Reference
allay nerve cap tl5515-1 allay nerve cap tl5515-2 delivery tips tl-7627
Tulavi Therapeutics
Summary: The Allay Nerve Cap is a bioresorbable hydrogel device used for the treatment and prevention of symptomatic neuroma. It is primarily used by surgeons specializing in peripheral nerve injuries.
FDA Clearance Information
Pathway
510K
Number
K252051 ↗
Decision Date
September 29, 2025
Product Code
SBG
Device Class
Class 2
Evidence
0 studies
The Allay Nerve Cap, manufactured by Tulavi Therapeutics, received FDA clearance via the 510k pathway on September 29, 2025. It is classified as a Class 2 medical device under product code SBG.
What It Is
The Allay Nerve Cap is a sutureless, bioresorbable hydrogel designed to treat and prevent symptomatic neuroma, a painful condition following peripheral nerve injury. The device works by encapsulating the nerve end, reducing mechanical irritation and neuroma formation. Its bioresorbable nature eliminates the need for removal, simplifying post-operative care.
Clinical Applications
The Allay Nerve Cap is used in surgical settings, particularly by orthopedic and plastic surgeons dealing with peripheral nerve injuries. It is applicable in cases where patients suffer from painful neuromas, often following trauma or surgical procedures. This device is beneficial in both acute injury settings and chronic pain management for patients with existing neuromas.
Indications for Use
The FDA-cleared indications for the Allay Nerve Cap include the treatment and prevention of symptomatic neuroma, a condition characterized by nerve pain following injury. It is intended for patients experiencing chronic pain due to nerve damage.
Practical Considerations
The Allay Nerve Cap is available in various sizes to accommodate different nerve diameters. It is designed for easy application without the need for sutures, reducing operative time. Clinicians should ensure compatibility with the specific nerve size and location for optimal results.
Related Literature
The linked study explored the use of the Allay Nerve Cap in treating and preventing symptomatic neuroma. The study highlighted the device's potential to simplify surgical procedures by eliminating the need for sutures and reducing operative time. Key findings suggest promising efficacy, although further research is needed to confirm long-term outcomes and broader applicability.
Frequently Asked Questions
What is the Allay Nerve Cap used for?
The Allay Nerve Cap is used for the treatment and prevention of symptomatic neuroma, a painful condition following peripheral nerve injury.
What specialties typically use this device?
Orthopedic and plastic surgeons specializing in peripheral nerve injuries typically use the Allay Nerve Cap.
What are the FDA-cleared indications?
The FDA-cleared indications include the treatment and prevention of symptomatic neuroma in patients with peripheral nerve injuries.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.