DeviceClearance

Product code SFD— Neurology

COAPTIUM Connect with TISSIUM LIGHT

Classification name
In Situ Polymerizing Peripheral Nerve Repair Device
Device class
Class 2
Regulation
21 CFR 882.5270
Advisory panel
Neurology
Total cleared
2
First cleared
Most recent

FDA classification definition

“An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.”

— U.S. Food and Drug Administration, device classification record for product code SFD under 21 CFR 882.5270, via openFDA

Market context for product code SFD

FDA has cleared 2 devices under product code SFD, all in 2025, filed by 1 applicant company. 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.

Top applicants under product code SFD

Recent clearances under product code SFD

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