510(k) Clearances
Data Validation
Duodenoscopes
Echo-endoscopes
Endoscopic Ultrasound (EUS)
FUJIFILM ED-530XT
Klebsiella pneumoniae carbapenemase]-producing K. pneumoniae
Olympus TJF-Q180V
OXA-48-producing
Patty Murray (U.S. Senator)
Pentax ED-3490TK
Soluscope
The Redesigned Olympus Duodenoscope Has Been Linked to a ‘Superbug’ Cluster The device's original design was recalled in January 2016 amid concerns about its safety.
March 21, 2017 (9:58 pm ET) — A “corrected” duodenoscope design introduced last year by the manufacturer to replace a recalled device has been linked to a “superbug” cluster, I…