FDA-Device2015-09-30Class II
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Olympus America Inc.
Hazard
New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.
Sold states
Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.
Affected count
6109
Manufactured in
3500 Corporate Pkwy., P.O. Box 610, Center Valley, PA, United States
Products
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2807-2015Don't want to check this manually?
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