Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L

Bronchoscope (flexible Or Rigid)

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Grasping Forceps Fg-214p, Single Use Grasping Forceps Fg-220p, Single Use Grasping Forceps Fg-226c, Single Use Grasping Forceps Fg-232l, Single Use Grasping Forceps Fg-804l.

Pre-market Notification Details

Device IDK200342
510k NumberK200342
Device Name:Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L
ClassificationBronchoscope (flexible Or Rigid)
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentSheri L Musgnung
Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley,  PA  18034 -0610
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-11
Decision Date2020-12-17

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.