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TULAVI THERAPEUTICS

Matched from indexed company URL: Tulavi Therapeutics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30275621693027562169TULAVI THERAPEUTICS1N2026-01-01160 Knowles Dr Los Gatos CA US 95032

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3303651365435990K252051allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627)SBG2025-09-29
3303651219369448DEN230061allay Nerve CapSBG2024-07-16

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SBG22025-09-29

GUDID#

allay™ Nerve Cap - Large Nerve Set - The allay™ Nerve Cap is a nerve cap made of an absorbable polyethylene glycol implant that provides a protective layer around the end of a transected peripheral nerve. The allay™ Nerve Cap forms in situ around a nerve end inside a temporary Cap Form. The hydrogel formed is a transparent, compliant nerve cover that conforms to and provides non-constricting encasement of the nerve end. The allay™ Nerve Cap provides a protective cover around the end of the nerve during the 3-month period associated with neuroma formation , after which the hydrogel is absorbed and cleared from the site within 8 months. The allay™ Nerve Cap - Large Nerve Set (5-7 mm) is provided in a sterile, non-pyrogenic for single use only.

Tulavi Therapeutics, Inc.

2024-08-05

allay™ Nerve Cap - Small Nerve Set - The allay™ Nerve Cap is a nerve cap made of an absorbable polyethylene glycol implant that provides a protective layer around the end of a transected peripheral nerve. The allay™ Nerve Cap forms in situ around a nerve end inside a temporary Cap Form. The hydrogel formed is a transparent, compliant nerve cover that conforms to and provides non-constricting encasement of the nerve end. The allay™ Nerve Cap provides a protective cover around the end of the nerve during the 3-month period associated with neuroma formation , after which the hydrogel is absorbed and cleared from the site within 8 months. The allay™ Nerve Cap - Small Nerve Set (1-4 mm) is provided in a sterile, non-pyrogenic for single use only.

Tulavi Therapeutics, Inc.

2024-08-05