FDA-Device2022-10-19Class II
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Olympus Corporation of the Americas
Hazard
Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters which were not designed for use with the VC-10, which can lead to serious injuries as it does not fit properly with the VC-10.
Sold states
Domestic distribution nationwide. Foreign distribution to Canada and Japan.
Affected count
4184 US; 191 OUS
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0078-2023Don't want to check this manually?
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