URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE

Choledochoscope And Accessories, Flexible/rigid

OLYMPUS CORP.

The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Urf-p2 Ureterorenofiberscope/choledochofiberscope.

Pre-market Notification Details

Device IDK912120
510k NumberK912120
Device Name:URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE
ClassificationCholedochoscope And Accessories, Flexible/rigid
Applicant OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
ContactDaniel J Dillon
CorrespondentDaniel J Dillon
OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
Product CodeFBN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-14
Decision Date1991-08-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170375078 K912120 000
04953170058950 K912120 000
04953170061516 K912120 000
04953170063114 K912120 000
04953170069048 K912120 000
04953170286988 K912120 000
04953170316593 K912120 000
04953170340154 K912120 000
04953170340307 K912120 000
14953170375054 K912120 000

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