FDA-Device2025-03-12Class II
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Integra LifeSciences Corp.
Hazard
Possibility for the obturator to break (separate).
Sold states
US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC.
Affected count
623 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1295-2025Don't want to check this manually?
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