FDA-Device2025-07-30Class II
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Olympus Corporation of the Americas
Hazard
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Sold states
International distribution to the country of Japan.
Affected count
11 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2143-2025Don't want to check this manually?
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