Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR

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 Guide Sheath Kit K-401, K-402, & Single Use Guiding Device Cc-220dr.

Pre-market Notification Details

Device IDK192164
510k NumberK192164
Device Name:Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
ClassificationBronchoscope (flexible Or Rigid)
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentJonathan Gilbert
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)
Regulation Medical SpecialtyEar Nose & Throat
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-09
Decision Date2020-03-06

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