Single Use Guide Sheath Kit-401, K-402

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-401, K-402.

Pre-market Notification Details

Device IDK212667
510k NumberK212667
Device Name:Single Use Guide Sheath Kit-401, K-402
ClassificationBronchoscope (flexible Or Rigid)
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentTeffany Hutto
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-23
Decision Date2021-09-22

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