510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230061Unknown

allay Nerve Cap

Tulavi Therapeutics, Lost Gatos CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN230061 is the FDA 510(k) clearance record for allay Nerve Cap, a class II device, cleared for Tulavi Therapeutics on under FDA product code SBG (In Situ Polymerizing Peripheral Nerve Cap). FDA's definition for product code SBG reads: "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...". FDA records list 2 510(k) clearances for Tulavi Therapeutics, from to . As of , FDA records show no recalls naming DEN230061.

Clearance record

Decision date
Received
(308 days to decision)
Product code
SBG In Situ Polymerizing Peripheral Nerve Cap
Regulation
21 CFR 882.5260
Device class
Class II
Review panel
Neurology
Applicant
Tulavi Therapeutics 160 Knowles Ave., Lost Gatos CA
Third party review
No

Clearances, product code SBG

Trailing 12 months

FDA records hold no clearances under product code SBG in the trailing twelve months.

FDA records show no clearances under product code SBG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SBG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260