FDA-Device2025-06-18Class II
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);
MicroAire Surgical Instruments, LLC
Hazard
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Sold states
Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
Affected count
1,451 eaches
Manufactured in
3590 Grand Forks Blvd, Charlottesville, VA, United States
Products
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1975-2025Don't want to check this manually?
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