DeviceClearance

Product code SBG— Neurology

allay Nerve Cap

Classification name
In Situ Polymerizing Peripheral Nerve Cap
Device class
Class 2
Regulation
21 CFR 882.5260
Advisory panel
Neurology
Total cleared
2
First cleared
Most recent

FDA classification definition

“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 environment to reduce the risk of formation of a symptomatic neuroma.”

— U.S. Food and Drug Administration, device classification record for product code SBG under 21 CFR 882.5260, via openFDA

Market context for product code SBG

FDA has cleared 2 devices under product code SBG between 2024 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SBG

Recent clearances under product code SBG

Data sourced from openFDA. This site is unofficial and independent of the FDA.