OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE

Forceps, Biopsy, Non-electric

OLYMPUS OPTICAL CO., LTD.

The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Xcyf-tp3 Cystofiberscope/nephrofiberscope.

Pre-market Notification Details

Device IDK032092
510k NumberK032092
Device Name:OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
ClassificationForceps, Biopsy, Non-electric
Applicant OLYMPUS OPTICAL CO., LTD. 34-3 HIRAI HINODE-MACHI, Nishitima-gun, Tokyo,  JP 190-0182
ContactMasao Wada
CorrespondentDerwyn Reuber
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeFCL  
Subsequent Product CodeFAJ
Subsequent Product CodeFDI
Subsequent Product CodeFGA
Subsequent Product CodeKGE
Subsequent Product CodeKNS
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-07-07
Decision Date2003-07-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170339424 K032092 000
04953170339417 K032092 000
04953170328817 K032092 000
04953170292521 K032092 000
04953170292323 K032092 000
04953170286964 K032092 000
04953170411182 K032092 000
04953170411144 K032092 000

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