FDA-Device2024-07-17Class II
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Integra LifeSciences Corp.
Hazard
Potential sheath damage that could lead to tissue damage and/or track hemorrhage.
Sold states
Domestic: NY, OH, & DC.
Affected count
14 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2331-2024Don't want to check this manually?
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